When it comes to Quality Assurance (QA), what are some of the major challenges that have been impacting the pharmaceutical industry lately?

The competition for high-quality QA professionals has always been an industry challenge, but since the pandemic, this has been exacerbated. With so many pharmaceutical companies competing for qualified candidates, turnover has increased, competition for resources is high, and compensation demands continue to rise. The job market has changed, with more individuals seeking work-from-home opportunities. Remote work can be difficult to offer for many QA roles in a clinical research organization (CRO) or a contract development and manufacturing organization (CDMO) where real-time, “on-the-floor” interaction is needed with clinical or manufacturing colleagues, and with customers and regulatory agencies.

Service providers that Quotient Sciences partners with have shared that they too are experiencing the challenges of turnover and high absenteeism. These strains can result in longer lead times, higher error rates, potential delays, and increased costs, which can impact the customer. At Quotient Sciences, we are focused on minimizing the impact that these challenges may have on our customers, and we strive to deliver the highest degree of quality for each program. We proactively take actions to minimize risks and conduct thorough investigations into any discrepancies, ensuring that corrections are implemented, and actions are taken to mitigate the potential for recurrence. 

The increased focus by many sponsors on developing new drugs that fulfill unmet medical needs or provide improved outcomes over currently available therapies has required CDMOs and CROs to seek ways to shorten timelines without compromising on quality or compliance. This in turn requires QA to drive quality system efficiency and support the delivery of integrated services aimed at reducing drug development timelines.  

In drug development and manufacturing, what role does Quality Assurance & Compliance play? What makes it so important, not just for the contract service provider or the sponsor but for the patient as well?

The Quality Assurance & Compliance function (herein termed “QA”) fulfill a number of crucial roles supporting drug development and manufacturing. QA is accountable for staying abreast of applicable global regulatory requirements and expectations and translating these into fit-for-purpose policies and procedures used by all colleagues to deliver safe and effective products. In a contract organization, QA also works with sponsors to ensure that their requirements are understood and integrated into any project-specific activities. QA maintains oversight of Good x Practice (GxP) work performed across the organization, ensuring that it is conducted in a compliant manner and serving as a coach and mentor for all colleagues to help ensure that they understand expectations and guide them on how to deliver quality in their roles. When quality issues arise, QA also serves as a risk manager. They collaborate with subject matter experts, which includes the sponsor, to evaluate risks and ensure the actions taken are commensurate with the level of risk, while consistently prioritizing the needs of the patient. The maximum effectiveness of QA’s role is best achieved when they serve as an engaged partner to the business, working collaboratively with all internal functions and externally with the sponsor, to proactively build quality into products and services. These actions ensure that quality and compliance objectives are integrated with business objectives, which benefit the contract service provider, the sponsor, and ultimately the patient. 

What keeps you up at night when it comes to some of the major Quality Assurance & Compliance predicaments in the drug development and pharmaceutical industry?

A few challenges that drug development organizations are facing today that keep me as a Compliance leader up at night include retention of a qualified workforce, the constant need for speed and agility, supply chain disruptions, and inflation and its impact on rising costs. 

Turnover is a major issue impacting our industry. To adapt to current workforce needs, employers are forced to reassess how work gets done. It is essential for businesses to respond quickly to retain their qualified workforce, but these types of changes must also be thoroughly considered so as not to create more business complexity or add long-term costs that cannot be effectively managed. The increased need for speed and agility in all aspects of operations adds additional strain on the workforce that can further compound the retention concern. 

Supply chain disruptions continue to impact the pharmaceutical industry. These challenges increased during the pandemic and have been further exacerbated recently due to other geopolitical events, resulting in delays in accessing materials needed to deliver drugs to patients in need and progress development of new drugs.  Organizations may need to quickly identify and qualify alternate materials or vendors, develop and qualify or validate new systems and processes, and deliver finished products under more stringent timelines. This is another example where speed and agility are essential but can also result in unanticipated errors. Quality management systems must be capable of facilitating agile working while still maintaining robust controls to detect deviations. 

Inflation and its impact on rising costs is another major challenge. Costs associated with materials, labor, utilities, and distribution continue to increase, which can impact an organization’s top-line growth and reduce cash needed for forward-thinking investments. Leaders must continue to seek opportunities to reduce costs, improve processes, reduce waste, and leverage technology to deliver products and services. Quality and compliance must remain a strong consideration when driving these improvements.    

Can you tell us about the latest quality systems or compliance project that you have been working on, and what are some of the technological and process elements that you leveraged to make the project successful? How will it benefit not only Quotient Sciences but also the customer?

One of the most significant recent investments in quality systems at Quotient Sciences was the implementation of an electronic document management system (eDMS) and quality management system (eQMS). Quotient Sciences recognized the need to establish an integrated quality management system that provided real-time visibility to documents and data, improved metric reporting and analysis, was easy to maintain, and was scalable to grow with our business. Veeva Vault was our chosen solution. 

Veeva has served as a common platform for harmonized processes across all Quotient Sciences sites, which include but are not limited to the management of controlled documents, deviations, customer complaints, change control, and corrective and preventive actions. These processes enable Quotient Sciences to deliver a harmonized customer experience and shorter response times. 

Since the implementation of Veeva in mid-2020, Quotient Sciences has continued to seek opportunities to expand system capabilities and continue our digital transformation of quality processes, with the focus on improving efficiency and effectiveness while maintaining compliance.

Which are some of the current and future technological trends that excite you in the Quality Assurance & Compliance arena that can better aid the drug development industry?

The drug development industry strives to remain on the cutting edge, continually seeking new or advanced therapies to fulfill unmet patient needs. Very few drugs that are in development make it to market. There is an immense amount of data produced for both successful and unsuccessful drugs alike. Seeing the emerging trend in industry to better utilize data to improve future drug development is incredibly exciting. 

Predictive analytics may be used to help predict drug performance, thereby potentially reducing timelines for new drug development and increasing the success of clinical trials, while reducing risks to volunteers and patients. This tool can also improve manufacturing process robustness, thus increasing supply chain reliability and reducing time to market. Overall, this can result in shorter drug development timelines, reduced costs, and higher success rates. It can also lead to better and more consistent product quality. Most importantly, predictive analytics can result in improved therapies being made available to treat patients sooner. 

The enormity of available data also supports advancements in data connectivity. Data silos have historically been common in drug development and manufacturing. Data resides in different sources that may be difficult to access and may not be easily combined with other data to provide a reliable holistic overview. Linking these separate data sets can help break down silos and improve delivery of the right data to the right people at the right time to support improved decision-making.     

Silos do not just exist in data. They have also been common across the supply chain, which can result in delays and disruptions in moving a drug through the development process. It is exciting to see companies, such as Quotient Sciences, who are offering integrated services that can shorten development timelines and costs to get drugs to patients faster. 

What Quality Assurance &Compliance standards should sponsor companies look for when selecting a contract service provider?

Prior to selecting a CDMO or CRO, sponsor companies should first seek to understand their own needs and priorities. Questions that sponsors should take into account include:

• To what extent are they looking to outsource versus manage internally?
• Are they looking for a company that has established systems and processes that will be used to execute the contract work, or will they be prescribing those processes? 
• Are they seeking a supplier for limited transactional work, or are they looking to cultivate a partnership that will span many projects?
• Are they seeking the lowest-cost service provider or one that offers differentiated services capable of managing complex programs? 

Once these needs are understood, the sponsor company should seek a partner with fit-for-purpose quality systems that provide flexibility, agility, and a strong compliance history. Other standards that sponsor companies should seek in their service provider include visible action-oriented metrics for quality, service, and delivery; a robust integrated Corrective and Preventive Action (CAPA) program with demonstrated effectiveness measures; and a robust quality management review program.  Additionally, sponsor companies should look for a contract service provider that is collaborative and promotes sponsor-to-provider, function-to-function (e.g. sponsor QA to provider QA) interactions. This will ensure open communication at the right levels between both parties while driving strong collaboration.

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Kimberly is an experienced compliance leader with over 25 years’ in life sciences.  Combining her technical and leadership capabilities, she works to identify creative solutions that balance compliance and business risk to achieve business results that meet regulatory expectations.  She has served in senior Quality leadership roles overseeing development, manufacturing, and distribution of pharmaceutical and medical device products supporting a broad range of therapeutic areas.  

Kimberly received her BS degree in Mechanical Engineering from West Virginia University, a MS degree in Engineering Science and an MBA from Penn State University, and a graduate certificate in Pharmaceutical and Medical Device Law and Compliance from Seton Hall Law School. 

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Introduction

Modified-release (MR) formulations are in high demand. For formulators, they enable drugs to be released in the optimal gastrointestinal (GI) locations to achieve and maintain desirable plasma concentrations for extended periods, avoiding undesirable excursions outside the therapeutic range. For patients, MR formulations provide the convenience of infrequent dosing with potentially greater efficacy and fewer side effects than similar, immediate-release delivery systems.

An impressive variety of MR formulations are possible, thanks to ongoing technological developments. Strategic selection of excipients and delivery technologies can yield MR formulations that fulfil very specific performance requirements, such as gastro-retention and sustained-, pulsatile-, or delayed-release formats. Nonetheless, throughout the past 20 years, the fundamental methodology for developing these formulations has stagnated. Initial formulations continue to be founded upon in vitro and preclinical test results, despite evidence that these data correlate poorly with pharmacokinetic (PK) drug performance in humans.1 The following will discuss a range of available formulation technologies, the challenges in MR formulation development, and the use of a design-space approach with on-demand manufacturing. This methodology enables critical-to-performance formulation adjustments during clinical conduct, saving time and cost, and reducing risk in MR drug development. 

The Challenges of MR Formulation

An ever-increasing number of polymers and formulation technologies allow finely tuned control of many aspects of drug release. Selecting and/or combining these technologies offers great potential for optimized oral drug delivery. However, managing all the variables and interpreting in vitro, preclinical, and available human clinical data to define a formulation strategy capable of achieving the desired PK performance is more difficult than many developers expect. Accurate performance prediction is crucial because miscalculations in planning for development or manufacturing are costly and often cause delays.

The abundance of Technology: A Blessing & Curse

Off-the-shelf and proprietary polymers help MR developers achieve their PK goals. Certain polymers are better suited for sustained or delayed release and may be designed to deliver APIs to specific GI target areas, depending on physicochemical, biomechanical, and human physiological factors influencing the site of release. The range of solid dosage forms offers further layers of complexity. This ever-expanding array of tools makes many MR modalities possible. Some options are shown in Table 1. Each delivery format has its own idiosyncrasies. In the first instance, understanding the target PK profile is crucial. What plasma concentration-time profile does the formulation need to deliver? Experience and expertise are then required to select and implement a rational formulation program based on API characteristics, such as solubility, stability in stomach acid, particle size, and bioavailability. Furthermore, human physiology factors (such as an absorption window, drug transporters, enzymes in the GI tract, and intestinal motility) can impact a product’s performance as it transitions through the intestine. Given these variables, being sure the formulation performs in vivo as it did in vitro can be challenging. A good CDMO will help developers find the best approach and select a technology to achieve the desired performance.

The Rocky Transition From Lab to Human

What is the best way to predict a formulation’s clinical performance? Ultimately, how an MR delivery system will perform in humans is unknown until clinical PK data becomes available, no matter what the in vitro and preclinical data indicated. Successful performance depends on an interplay between the drug molecule, the formulation, and the gastrointestinal environment. Despite their long-term, widespread use for this purpose, in vitro and preclinical studies cannot always be relied upon to predict how formulations will perform in humans.2,3

There are many reasons why animal studies are not necessarily predictive of how a drug will behave when administered to humans. The pHs in the various segments of animals’ GI tracts differ from those in the corresponding segments in humans. Animals’ stomachs exert different peristaltic wave forces and have different gastric-emptying rates as well, so diffusion rates, release rates, and PK profiles are not always representative. The best model for a human is a human.

A traditional clinical investigation for developing an MR system would be to test 2-3 fixed-formulation prototypes, such as a slow formulation, a fast formulation, and perhaps one in between based on in vitro and preclinical data, and hope one achieves the desired PK profile. But if these combinations miss the target PK profile, an additional time-consuming development cycle will be required, incurring a delay of 12-18 months and additional outsourcing costs of $1.5-$2.5 million. In contrast, using a design space concept will produce the required PK profile efficiently, in a single development cycle.

The Design Space Study Meets Real-time Manufacturing

The most obvious question when planning to develop an MR dosage form is: What is the starting composition and dose? In vitro dissolution studies are an invaluable tool to inform formulation development. However, there is considerable uncertainty as to whether a fixed formulation that achieves the desired release rate in vitro will also deliver the required performance in humans. If the starting formulation misses the mark completely, a second clinical study with an adjusted starting formulation will be required, leading to escalating costs and time delays. Fortunately, by implementing adaptive design strategies such as the design space (DS) approach, developers can mitigate this risk.

The Design Space Concept

The International Conference on Harmonisation (ICH) and FDA define DS as: The multidimensional combination and interaction of input variables (e.g., material attributes) and process parameters that have been demonstrated to provide assurance of quality (ICH Q8).4

These regulatory definitions are focused on late-stage development, and the importance of defining a “safe space” within which changes in product and process parameters will not affect clinical performance. The same principles, however, can be applied to early development to maximize the potential to optimize formulations within a single clinical study. Rather than specifying exact values for API and excipient contents, developers can set ranges for these critical-to-performance parameters in the regulatory application. By varying the quantitative levels of these components during clinical conduct, product performance can be influenced and the formulation optimized based on human data. These DS ranges represent acceptable, safe limits based on toxicology studies and PK data collected earlier. Product quality is ensured through the inclusion of technical batch data in regulatory documentation. Approval of a complete DS gives developers leeway to adjust formulations as needed within the pre-approved ranges during study conduct. This freedom mitigates risk in MR formulations by giving the Phase I clinical trial process the best possible chance of achieving the desired drug delivery profile – without the need for repeat development cycles.

How Design Space Maximizes Trial Flexibility

The DS concept can be applied to any formulation, drug product, or dosage form. The goal in MR formulations is to address all the adjustable, critical-to-performance parameters that can influence release rate and PK profile. While mapping two variables are common, it is possible to define the DS for as many as are relevant.5 For example, any of the following parameters could be considered as part of the DS:

• API dose/concentration
• Functional excipient content
• Drug: polymers ratio
• Surface area volume ratio
• Coating composition/thickness

Extremes of release rate can be developed in vitro, and the corresponding critical parameter values may be used as the minimum and maximum values to define the DS – the corner points (Figure 1).

Any formulation within this map may be manufactured and dosed without any regulatory amendment or notification. As clinical results develop, trial medications will be adjusted accordingly to optimize the drug-release pattern and increase or decrease the dose as required.

How CRO & CDMO Functional Integration Enables Real-Time Manufacturing & Shrinks Timelines

The flexibility a DS concept affords is only beneficial to the extent that manufacturing can keep pace with the clinical trial dosing modifications. Seamlessly integrating a manufacturing facility with the clinical testing organization running the study can shrink the time between decision points and restart the trial with the next iteration of drug product (Figure 2). Overall benefits of applying this rapid formulation development and clinical testing approach on demand, as products evolve in the development cycle include the following:

• Timeline shortened by more than 6 months
• Cost of outsourcing reduced by $750,000-$1.5 million
• Formulation selected based on clinical data
• Minimal API waste
• Seamless optimization of formulations for scale-up to commercial manufacturing

Pharmaceutical development teams from more than 50 pharmaceutical and biotechnology companies worldwide have completed more than 100 programs like this while developing optimized MR formulations for small molecule drugs across all major therapeutic areas.

Case Study

Development & Optimization of an MR Formulation Without Relying on Predictive Laboratory or Preclinical Models

A mid-size pharmaceutical company wanted to develop a once-daily format for an existing immediate-release (IR) formulation. An attempt to develop an MR matrix tablet formulation by traditional methods failed to achieve the desired PK profile, and resulted in Cmax related adverse events and sub-optimal therapeutic levels. The company enlisted an innovative CDMO’s help to develop the required formulation using a DS approach with dose and release rate (as determined by HPMC content) as the key variables.

During the development phase, technical batches with 14-day stability data were produced for the four corners of the design space -– the extremes of each variable. These batches were fully characterized using qualified analytical methods in support of the regulatory filing.

Once the application was approved, the clinical PK study in healthy volunteers began, with an initial IR reference period followed by sequential, fasted trials. The initial prototype formulation, within the design space, was determined by PK modelling. Each set of emerging PK data drove selection of the next MR prototype, which was manufactured, quality control tested, and released for dosing without additional approval or stability studies, just days before the next test period. This cycle ended when the PK profile fell within the desired range. Results are shown in Figure 3. One final round was conducted with fed study patients to test the food effect on the PK of the final formulation. This approach identified a tablet prototype with Cmax < 40% and C24 > 200% relative to the IR tablet in 7 months.

Through the integration of formulation design space, real-time GMP manufacturing, and an iterative sequential pharmacokinetic study, an HPMC matrix tablet with desired PK characteristics was developed. Human PK data guided formulation composition, eliminating the need to rely on surrogate, non-predictive laboratory or preclinical data.

OPERATIONAL CHALLENGES: MEETING REGULATORY EXPECTATIONS

To succeed in applying design space concepts to de-risk and expedite clinical trials, scientific and regulatory expertise must go hand in hand. In-depth understanding of the evolving clinical trial regulatory environment will ensure the preparation of high-quality IND applications and institutional review board (IRB) submissions that will satisfy regulatory authorities.

To approve a DS concept, authorities will first need to know how it is mapped: which critical material, process parameters, and/or product quality attributes are the intended variables. The justification package must then provide the following:

• Assurance that systemic exposure of the drug will not exceed that previously demonstrated to be safe and tolerated in humans
• Well-established evidence of safety for all excipients
• Well-established relationship between excipient variables (e.g., molecular weight or levels) and release rate
• Logic of the design space extremes – for example, is the API dose range reasonable based on a sufficient body of supporting information?
• The minimum (therapeutic efficacy)
• The maximum (toxicity/adverse events data)
• Evidence of product quality and stability within the DS to support the duration between manufacture and dosing

To ensure the strongest possible dossier, a collaborative relationship with the IRB is extremely helpful. A CDMO with regulatory personnel who routinely present DS concepts is most likely to achieve a seamless submission and approval process for this type of Phase I clinical trial application – provided that the science and production are impeccable. Successful 14-day make-test cycles demand operational speed and excellence with strong project leadership to integrate clinical and manufacturing activities while managing logistics.

Conclusion

Developing MR formulations that fit a target PK profile is far from simple, with many potential delivery technologies to select from and much uncertainty regarding performance in a physiological system. Use of a DS concept saves time and removes uncertainty surrounding achieving the clinical performance of a formulation. With the flexibility to vary the formulation as the clinical trial progresses, a DS concept diminishes risk by increasing the likelihood that the desired PK profile will be achieved relatively quickly, without the need for additional regulatory approval.

An integrated operational setup allows developers to take maximal advantage of DS concepts through the interplay of manufacturing and clinical testing. Through an iterative make-test cycle, a series of prototypes are rapidly reformulated based on emerging clinical data until the desired performance is achieved. This approach accelerates timelines and greatly diminishes the risk of failing to achieve the desired product.

The advantages of combining a DS approach with real-time, on-demand manufacturing include the following:

• Faster drug development and formulation optimization
• Lower R&D costs
• Lower risk
• Science-based product development
• Seamless transition to Phase II drug product and commercial manufacturing

Enlisting help from a partner with extensive experience in design space, the regulatory expertise to gain approval for them, and the operational capacity to provide real-time manufacturing will ensure successful implementation.

References

1. Pound P, Ritskes-Hoitinga M. Is it possible to overcome issues of external validity in preclinical animal research? Why most animal models are bound to fail. J. Transl. Med. 2018;16:304. doi.org/10.1186/s12967-018-1678-1.
2. Grass GM, Sinko PJ. Physiologically based pharmacokinetic simulation modelling. Adv. Drug Deliv. Rev. 2002;54(3):433-451. doi.org/10.1016/S0169-409X(02)00013-3.
3. Musther H, Olivares-Morales A, Hatley OJD, Liu B, Hodjegan AR. Animal versus human oral drug bioavailability: do they correlate. Eur. J. Pharm. Sci. 2014;5:280-291.doi.org/10.1016/j.ejps.2013.08.018.
4. USFDA. Conference on Harmonization (ICH) and FDA Guidance for Industry, Q8 (R2) Pharmaceutical Development 2009. https://www.fda.gov/media/71535/download. Accessed May 30, 2019.
5. McDermott J, Scholes P. Formulation design space: a proven approach to maximize flexibility and outcomes within early clinical development. Therapeutic Delivery. 2015;6(11):1269-1278. do

Richard Castledine talks to Pharmaceutical Technology

Each molecule has unique requirements and challenges, and a variety of solutions for drug substance synthesis and manufacturing are available, so it is important to have a keen understanding of the strategies that can help streamline these processes

Drug substance plays a key part in ensuring a drug program achieves its major milestones, keeps to budget and delivers on its corporate goals. As every molecule and development program is unique, there is no single drug substance synthesis and manufacturing solution, so understanding what processes and technologies are available, what strategy is best, and who to partner with is key. 

To increase the likelihood of clinical success, drug developers must identify challenges and potential red flags early on in the candidate selection stage. This minimizes downstream risks, helps to determine a suitable synthetic route for scale-up, and facilitates an easier transition into the formulation development phase. As a result, pharmaceutical companies increasingly prefer to partner with contract development and manufacturing organizations (CDMOs) that have end-to-end capabilities, where knowledge sharing between process research and development (PR&D), analytical, and formulation teams leads to rapid parallel development and optimization of both drug substance and drug product. Placing traditionally siloed drug substance and drug product development activities within a single organization that also has commercial manufacturing capabilities accelerates clinical development and builds in quality and robustness of supply.

Timing is everything, and successful drug substance development and manufacturing depends on having the expertise, agility, and flexibility to solve any problem that may arise in a timely fashion. Quotient Sciences, a drug development and manufacturing accelerator, brings together a depth of knowledge, breadth of experience, and cutting-edge technologies to solve complex drug substance and drug product problems related to scalability, efficiency, and economy. They provide fully integrated drug substance, drug product, and clinical services spanning from candidate selection through commercial manufacturing under a single organization. This integration of services enables them to quickly identify challenges and develop solutions based on real-time data before they become bottlenecked, which in turn lowers the risk of timeline delays for their customers.

Important considerations for drug substance development

Polymorphic form issues

Understanding the polymorphism of a drug compound plays a key role in both drug substance and drug product development because it can negatively impact the downstream stability, solubility, and bioavailability of a drug. Polymorphic form changes are a frequent issue in drug development, so the key is ensuring only the desired polymorph is produced, otherwise, the consistent efficacy of the final drug can be affected by changes to its solid-state structure. A full analysis of the drug’s solid state will indicate its propensity to form various polymorphs.

These polymorphs all have the same chemical composition and synthetic route, but they have varied crystalline structures with different physical properties such as melting points. It is important that they are screened to select the best solid-state for formulation development and manufacturing. Recrystallizing the drug compound under different conditions will help determine the likelihood of the occurrence of varied thermodynamic and kinetic solid products.

Quotient Sciences uses computational modelling and simulation to narrow the field of polymorph possibilities, which acts as a predictive tool for choosing the right solid-state formulations to move forward into the clinic.

Applying real-time data

According to Richard Castledine, Head of PR&D, Drug Substance, at Quotient Sciences, “We are fortunate to have a wide array of state-of-the-art process analytical technologies (PAT) at our Alnwick, UK, facility, which we use to generate real-time data for processes that are under development. We are keen to increase the digitalization of our PR&D space, enabling us to make greater use of modeling predictive tools to make faster, better-informed decisions.”

“These tools help us understand more precisely the mechanisms by which impurity generation and reaction progression are occurring. When we couple that with other techniques, such as the design of experiments (DoE), we can develop a robust appreciation of the process design space and understand the parts of the chemical space that give consistent purity profiles and consistent yields, which in turn delivers consistent throughput,” says Castledine.

“PAT enables us to make use of software and artificial intelligence (AI) as a predictive control tool. This means that when we go into the laboratory, we are confirming those results rather than exploring the whole space. The benefits to the customer are that it significantly shortens development time and makes the whole process more cost-effective.”

Analytical method development

When developing a drug substance manufacturing process, considering the impurities that are produced is as important as the drug substance itself. “By carrying out analytical method development in parallel to the development of the active pharmaceutical ingredient (API) synthesis, we can readily identify and quantify new impurities, which informs the direction of work undertaken by our development chemists,” shared Castledine.

“This provides understanding from a very early stage of development about the fate of impurities and control points within the synthesis. It also means that timelines can be reduced, so that non-Good Manufacturing Practice (non-GMP) demonstration batches can be started as soon as the synthetic methodology is available and stability studies of the API can be initiated as soon as enough material has been prepared.”

Determining the best manufacturing process – traditional batch vs continuous flow

When evaluating a new synthetic route for a target molecule, one of the first decisions to be made is whether to employ a traditional batch-based synthesis or to make use of continuous processing methodology.  Both approaches offer advantages and disadvantages, and the optimum solution will vary on a case-by-case basis. Parameters to be considered are the rate of reaction, the volumetric efficiency of the process, and the presence of any heterogeneous, reactive, or high-energy materials in the reaction mixture.    

Quotient Sciences has access to large-scale batch and continuous processing assets and are able to design the optimum equipment set-up to match the chemistry of the transformation required rather than compromise the chemical process to fit the ubiquitous batch reactor. Where continuous processing options are the best match, they often offer increased process reliability, improved impurity control, greater compatibility with PAT, and a faster path to scale-up.    

Streamlined processes to reduce time to market for drugs

Integrated drug substance and drug product services

When asked about some key processes that Quotient Sciences provides to clients that help streamline drug substance development and reduce time to market, Castledine states that the key improvement is the drug substance to drug product integration.

“Within Quotient Sciences, we have fully integrated drug substance, drug product, and clinical testing services, which gives us the ability to break down traditional industry silos, allowing us to streamline the outsourcing process for our customers.”

“Integrating all activities under a single organization encourages better workflows and processes and builds close relationships between multidisciplinary experts. We pride ourselves on cross-functional communication and knowledge sharing, and our drug substance team members work very closely with our colleagues in formulation development and drug product manufacturing to ensure the best outcome for our customers’ programs,” he says.

“As soon as we start to develop an API, we begin having conversations about the quantities that are available versus what is needed for the clinical program. We also discuss formulation strategies, timelines/decision points, and the customer’s desired target product profile (TPP).”

“Drug substance team members also provide the characterization and screening data that is generated as part of API crystallization, to inform the formulation development team about how the API is likely to behave under certain conditions,” says Castledine.

“For drug substance chemists,” he says, “the most useful and valuable information is understanding what kind of polymorphs form under different conditions. This data is also critical for drug product formulation development because it can give an early indication of whether a molecule may or may not have stability or solubility issues.”

“Understanding a molecule’s behavior is key when trying to design a formulation for the clinic. Technology selection is based on the solubility and permeability of a compound utilizing the Developability Classification System (DCS), so the sooner that this data is available to a formulation team the shorter the lead time to a developed formulation,” he says.

“Typically, in the CDMO space, polymorph screening, drug substance, and drug product services are all conducted at separate organizations,” says Castledine, “in a siloed manner and at different times in the development lifecycle. However, at Quotient Sciences, we can screen polymorphs in-house and provide that data in real-time to both drug substance and drug product development teams to aid in the development of our clients’ programs. Having these capabilities within a single organization also allows us to make informed decisions based on emerging data and rapidly accelerate our customers’ development timelines.”

Quotient Sciences’ drug substance services

Quotient Sciences’ capabilities in drug substance services include:

• PR&D
• Analytical method development and validation
• Salt selection and polymorph screening
• Non-GMP, GMP, and commercial drug substance manufacturing
  Pre-formulation development
• DoE
• Thermal hazard and reactivity assessment
• Stability testing
• Proven acceptable range (PAR) and critical process parameter (CPP) determination
• Impurity identification and synthesis
• Genotoxic impurity (GTI) assessment
• Process validation
• Investigational Medicinal Product Dossier (IMPD)/Investigational New Drug Application (IND) preparation
• Technical investigations
• Freedom-to-operate (FTO) assessments

Developing workable API solutions

When asked about some issues Quotient Sciences has faced and solved as an end-to-end CDMO for clients, Castledine shared, “We worked on a project where the API was showing good data in terms of its efficacy, but the client was having significant difficulties developing a sufficiently soluble formulation.”

“We were tasked to develop a second-generation compound that would benefit from improved solubility. Alongside the development of the second-generation compound, we also undertook further formulation development work on the original molecule and were able to develop a workable formulation for the customer’s first molecule,” he says.

“The advantage to the customer was that they no longer had to switch to their backup candidate and were able to continue with their first-generation compound, which was more advanced in the development lifecycle. We have subsequently become the primary drug substance supplier to that client and are progressing the project through to commercial validation and supply under a single organization.”

When asked to describe a service that Quotient Sciences provides that is unique in the drug substance design and production field, he explains, “Our approach to integrating drug substance synthesis and drug product manufacturing reduces risks and overall client timelines.”

“Delivery of the first GMP batches of an API in development is typically on the critical path,” shared Castledine. “To address this, we streamline and integrate the activities leading up to this point to remove barriers and reduce timelines. We provide pre-approved analytical methods and manufacturing instructions to our GMP facility to initiate manufacturing. It is also helpful to have some stability data at this stage, either real-time or accelerated, to assign a retest period to the first batch of API at release.”

“Furthermore, our commitment to embracing new and emerging technologies means that we are at the forefront of innovation regarding drug substance synthesis, which allows us to access reaction conditions that are out of reach of many of our competitors. From a customer perspective, this means that we are able to pursue more innovative solutions, reducing overall costs and getting new medicines to market faster.”

In summary, there are many challenges and considerations that drug developers must be aware of before kicking off their drug substance program.  Having a clear understanding of your molecule and its behavior, along with selecting the best manufacturing process, will help guide decision-making, aid downstream development, and move your drug substance off the critical path. In addition, leveraging a partner with in-house drug substances, drug product, and clinical capabilities can provide significant efficiencies and increase the potential for both clinical and commercial success.

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Nottingham Festival of Science and Curiosity 2022

The Nottingham Festival of Science and Curiosity is back with a renewed vigour for all things scientific and curiosity-inspiring and with a programme brimming with activities for all the family across the county. Celebrating its seventh anniversary, the festival will be running from 7-16th February. The festival is all about providing opportunities for people in Nottinghamshire to be inquisitive, ask questions and let curiosity lead the way!

Quotient Sciences, a Nottingham, UK based drug development and manufacturing accelerator, will be supporting the festival once again, continuing its commitment to help the festival get science out of the labs and into the everyday lives of local people. A group of volunteers from across Quotient Sciences organisation have been working with the festival team to develop exciting medicine-related activities for a local primary, FE college and for members of the public.

Peter Scholes, Quotient Sciences’ Chief Scientific Officer said “We’re delighted to be participating in the festival and have the opportunity to show our continued support for this important community event. As a local science-based business originating in Nottingham 30 years ago we recognise the importance of stimulating interest and to demonstrate the positive & valuable impact that science has on our everyday lives.

Among the Festival highlights is The Curiosity Show, reinvented from last year's Wollaton Watch, a series of five hour-long children’s TV shows broadcast live, 4-5pm on Notts TV, which will feature live science demonstrations, interviews and try-at-home activities, as well as exploring all things curious across Nottinghamshire. The festival magazine is back for a second year with a brand new look, exciting new content and a range of fun activities for all the family. 

Megan Shore, the festival producer said “We’re so excited to be able to work with Quotient Sciences to bring the festival back out into spaces across Nottingham and we’ve put together such an exciting lineup of activities, especially including some in-person workshops! We’re looking forward to engaging with new audiences, celebrating all the wonderful science happening in our region and hearing what people across Nottingham are curious about.”

For more information including detailed event listings please visit www.nottsfosac.co.uk and follow the Festival on Instagram, Facebook and Twitter @NottsFOSAC #FOSAC22 #CuriousNotts

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For more information, please contact Festival Marketing and Communications Lead Jaskirat Kaur [email protected] or Festival Producer Megan Shore can be available for interview.

About Quotient Sciences
Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we save precious time and money in getting drugs to patients. Everything we do for our customers is driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast. Because humanity needs solutions, fast.  For more information visit www.quotientsciences.com.

Nuformix plc (LSE: NFX), a pharmaceutical development company targeting unmet medical needs in fibrosis and oncology via drug repurposing, is pleased to announce that following the Company's signing of an exclusive global licensing agreement with Oxilio Ltd ("Oxilio") for NXP001 on 13 September 2021, Oxilio has progressed the product and signed a significant service contract with Quotient Sciences Ltd ("Quotient Sciences") to support the formulation development of NXP001. NXP001 is a proprietary new form of aprepitant which is currently marketed for cancer chemotherapy induced nausea and vomiting ("CINV").

Under the contract Oxilio will work with Quotient Sciences, a drug development and manufacturing accelerator, to identify and evaluate the cocrystal formulation of aprepitant to deliver optimal bioavailability for the treatment of CINV.

Quotient has prior experience of working with the Nuformix NXP-001 co-crystal and previously developed a capsule and a powder for oral suspension formulation, evaluating its performance in a relative bioavailability study versus EMEND (a branded aprepitant).

Quotient will prepare for Oxilio CMC (chemistry, manufacturing and controls) batches and stability data to support a clinical trial application for the new formulation of NXP001.

The Company looks forward to providing further updates on Oxilio's progress with NXP001 in due course.

Commenting, Alastair Riddell, Executive Chairman of Nuformix, said: "We are very pleased to see the progress Oxilio is making with NXP001. Under the exclusive licence we signed with Oxilio we received an upfront payment, expect to receive milestone payments when the product completes clinical trials and ultimately royalties on any sales. This arrangement is allowing Oxilio to progress NXP001 without cost to the Company whilst we focus on progressing our two lead assets, NXP002 and NXP004. In relation to NXP002 and NXP004 we continue to make significant progress and I look forward to making further announcements in due course."

About Oxilio 
Oxilio is a privately held pharmaceutical development company focused on repurposing known drugs for the treatment of cancer through a programme of corporate alliances coupled with rapid proof of concept clinical development. Oxilio will develop and seek to exploit NXP001 globally for the treatment of cancer. It is focused on alleviating the current dilemma of a shortage of effective drug candidatesthat have potential as new cancertherapies- by adopting a drug repurposing strategy (identifying new uses for approved or investigational drugs that are outside the scope of the original medical indication). The major advantage of this approach is that the pharmacokinetics- pharmacodynamics and toxicity profiles of these drugs are already reasonably well established. Thus- drug repurposing is a less risky development route with substantially lower associated development costs. The agreement with Nuformix allows Oxilio to focus on developing rapidly a unique formulation and dosage form with NXP001 and progressing into the clinic. For more information- please visit www.oxilio.co.uk.

About Nuformix
Nuformix is a pharmaceutical development company targeting unmet medical needs in fibrosis and oncology via drug repurposing. The Company aims to use its expertise in discovering, developing and patenting novel drug forms, with improved physical properties, to develop new products in new indications that are, importantly, differentiated from the original (by way of dosage, delivery route or presentation), thus creating new and attractive commercial opportunities. Nuformix has an early-stage pipeline of preclinical and Phase I-ready assets with potential for significant value and early licensing opportunities. https://nuformix.com/

About Quotient Sciences
Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we save precious time and money in getting drugs to patients. Everything we do for our customers is driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast. Because humanity needs solutions, fast.

Reducing drug development risks & timeline delays: An Integrated Bioanalytical & Pharmacokinetics (PK) Strategy

Delivering an effective integrated bioanalytical and pharmacokinetics (PK) strategy – in even the most challenging of circumstances.

Stuart McDougall, VP of Bioanalytical Services, Quotient Sciences, has been in this business since 1988. Here, he discusses the evolution of the company and how it has overcome the challenges thrown up by the Covid-19 pandemic.

As it stands today, bioanalytical departments or companies offering bioanalytical services, such as contract research organizations (CRO’s) are often separate from pharmacokinetic (PK) departments or companies that offer PK services. These industry silos create inefficiencies and time delays in getting data analyzed, resulting in slower decision-making in drug development. Being able to integrate bioanalysis (the sample analysis) and pharmacokinetic analysis (the data analysis and interpretation) under a single organization simplifies and streamlines the drug development process and accelerates timelines.

Q: What is your background in this sector?

A: I’ve been working in the pharmaceutical industry since 1988. Quotient’s Alnwick facility was part of Sterling Winthrop when I joined, which then became a Sanofi R&D site. My first job was in drug metabolism and pharmacokinetics, mainly working with radiolabelled drugs.

I then led the bioanalytical services group for over five years, and when a global CRO purchased this site in 2011, I remained in the same discipline but was also part of their bioanalytical services executive group. When Arcinova was formed in 2016, we massively increased headcount and there was a lot of investment in new mass spectrometers. We significantly grew as an organisation, I think it was nearly a five-fold increase in growth over five years and will continue to grow in both headcount and capacity now as Quotient Sciences.

Q: What are the components of a successful bioanalytical and pharmacokinetics strategy? 

A: An essential piece of information from a clinical trial is the pharmacokinetic data, that’s where you make the decisions on drug absorption and exposure. But you only make the pharmacokinetic decisions if you have concentration data, and concentration data comes from the plasma blood samples from the patient. So, it’s that ‘bedside to bench’ part that we look after. And then our in-house pharmacokinetic experts take that data and interpret that into what it means for the drug.

Q: How does an integrated strategy help clients move from one stage of development to another (E.g. candidate selection to preclinical, preclinical to clinical, FIH to POC)?

A: You really need to understand what your customer’s needs are, and to understand what stage of drug development they are at. At Quotient, we have a very science-rich culture with a significant amount of knowledge in drug development, and we work with our clients in collaboration. We possess a dedicated method development team, most being PhD level, with more than 100 years of experience, who have developed over 400 bespoke mass spectrometry-based assays. They employ great science and agility to solve problems in order to arrive at a quality assay that achieves the exposure data for your drug, whether it’s supporting a preclinical or clinical study.

Speed is everything when it comes to developing our client’s drug programs. It’s part of Quotient Sciences’ manifesto: “Molecule to Cure. Fast.” If we can accelerate drug development, then that’s positive for patients, customers, as well as humanity in the broadest sense, obviously.

Q: Why are such strategies important for reducing risks and delays in drug development?

A: The attrition rate from non-clinical development into a registered drug is high, with typically, less than one in 250 molecules that will make it through the process

By integrating bioanalysis and pk analysis we are able to provide customers with a well-rounded view of their molecule’s behavior and provide them with critical data that will allow them to make informed decisions going toward their next milestone. This robust data package aids in developing biopharmaceutics strategies to optimize the chances of success of your molecule in the clinic.

Q: How has a bioanalytical capability helped Quotient Sciences reduce delays and streamline drug development?

A: Quotient was already a drug development accelerator, and their Translational Pharmaceutics™ platform allows clients to quickly develop, manufacture and test new dosage forms in clinical trials.

By adding bioanalysis to the already integrated clinical pharmacology and pharmaceutical development capabilities, we can seamlessly bridge from the clinic, through sample analysis, sample management and logistics all the way to data arriving at the pharmacokinetics team. And because we’re all part of one organization, a lot of those points can be very slick.

This ensures the right samples are collected at the bedside, then processed the right way. The samples are then shipped up with speed to the bioanalytical facility. Samples are then rapidly analyzed in an accelerated timeline. We will go through a single ascending dose (SAD) cohort in less than three days from point of receipt, to the day the audited data is sent to our pharmacokinetics (PK) experts, so they can then do the PK processing, and then feed back to the clinic with the exposure data and the safety data. It’s that speed of looking at the data, and then moving on to the next stage that’s incredibly beneficial to our customers.

Q: How have your customers reacted to broader service offerings?

A: Generally, it’s been a very positive reaction from our customers. We’re breaking down the traditional, inefficient siloes in industry. Customers are wanting to outsource more and are looking for a trusted partner who can seamlessly move them through stages of development. We are able to assist them by providing multi-disciplinary guidance and recommendations that span bioanalysis, drug metabolism & pharmacokinetics, clinical pharmacology, formulation development and product manufacturing all at one organization.

An ideal bioanalytical team would disappear into the background, only looking after the mechanics from bedside to bench. The people that are ‘on point’ are the pharmacokinetic team. We are active contributors across the lifecycle of the program, collaborating with our in-house clinical and development teams to ensure the best outcome for the product, the customer and the patient.

Q: How do you take risk out of the process?

A: For Quotient Sciences, it is literally that synergy between the clinic to the lab. Everything takes place at one organization, from sample management, to sample logistics, to discrepancy resolution. This offering takes a lot of uncertainty out of it, which in turn takes a lot of risk out of the client’s process.

I’ve been discussing internally how to streamline the process even more by using 2D barcoding, where the barcode is attached to the bottom of the sample tube. We then could design the whole process from beginning to end, including the data flow.

I’ve worked with a multitude of clients around the world – and they’ve shared that this hasn’t been done yet at any of the organizations that they’ve worked with. If we’re doing all those things internally at Quotient, we can use a 2D barcode process, and it would streamline the process for our customers and give them a clear sightline to where all their samples are. That’s the front end.

The next part of the process is the data that comes from the bioanalytical lab. The information that comes from the lab is essentially a concentration of data, nanograms per mL which are associated with a time point and a patient. The data goes to our in-house PK team in the format that they need, so that they can then bring it into their PK software, without any questions or discrepancies, or data interfacing problems. Since this takes place under one organization, we de-risk the possibility of any discrepancies or miscommunication because we’re now sending data back and forward between Quotient facilities and not to external organizations. That’s another synergy and a huge benefit to our customers.

Q: What about data transfer?

A: Every client has a very different way of delivering and accepting data. In Quotient, we have a data transfer agreement. We use a LIMS system for our bioanalytical services. This system allows us to use barcode scanning to check samples in, to easily track their chain of custody and allows us to send the data out quickly. 

Q: How has Covid-19 affected Quotient Sciences’ business?

A: At Quotient, we have been very fortunate to have been able to sustain essential operations throughout the COVID-19 pandemic and support the continued progress of customer programs. Our internal teams have worked diligently to put in place procedures to ensure employee safety and awareness across all our global sites.  Regarding our customers, many shared that they had experienced a slowdown with their patient trials as recruitment became more challenging.

Q: How does this affect business continuity?

A: Many of our clients are asking us about our business continuity plan for Covid. We implemented Covid procedures across all our global sites to help minimize exposure in the workplace and layer controls to reduce risk. These procedures have helped create a safe work environment for our colleagues, and support the continuity of business to ensure client projects continue to run smoothly.

Like every business, we had to work around various challenges, such as global shortages of PPE. Fortunately, we have been able to maintain of good supply chain and have a trusted set of suppliers that enabled us to source needed materials and continue supporting our customers’ programs without any downtime.

NOTTINGHAM (UK), February 18, 2022: Oxilio signed an exclusive global licensing agreement with TRx Biosciences on 20th October 2021 for the use of their platform technology to support the development of Oxilio’s formulation, OXL001. Oxilio has since progressed the product and nowsigned a significant service contract with Quotient Sciences, a drug development and manufacturing accelerator, to support the formulation development and preparation of clinical trials for OXL001.

Mark Egerton, CEO of Quotient Sciences said, “By leveraging our integrated development and clinical testing platform, Translational Pharmaceutics®, Oxilio and TRx Biosciences will have the flexibility to adjust formulations based on emerging clinical data within their study, enabling us to improve their likelihood of success, reduce their development time and ultimately get new medicines to patients faster. We look forward to working with both companies as we prepare to take OXL001 into the clinic later this year.”

Commenting, Oxilio Director Dr Simon Yaxley said: “Quotient has significant capabilities for scientific innovation and adaptation which will further complement Oxilio’s already substantial scientific capacity. We look forward to taking Oxilio’s highly promising formulation OXL001 into the clinic later this year which, if successful, offers tremendous near-term potential benefit for cancer patients.”

About Oxilio
Oxilio is a pioneering pharmaceutical drug development company improving cancer treatment through rapid, cost-effective drug development. Our mission is to identify, repurpose and commercialise existing drugs to address unmet needs in cancer therapy. We find new uses for old drugs, a proven approach that involves less risk, time and cost to bring a drug to the marketplace. Through repurposing, reformulation and gold standard modelling and simulations, we are fast-tracking disruptive drug development at speed and at low cost. For more information, visit oxilio.co.uk.

Oxilio Company Contact
[email protected]

About TRx Biosciences
TRX’s technology enables targeted oral drug delivery to specific organs, cells and tissues in cancer, CNS and respiratory diseases and diseases of the immune system using a clinically and commercially proven approach. Our bio-enabling delivery mechanism addresses solubility and permeability limitations simultaneously. Well-absorbed drugs can then be highly targeted towards specific cells and tissues to best leverage their pharmacology. Our data demonstrates that TRx technology has the potential to significantly enhance the design and development of existing and future small molecule-based therapies. For more information, visit trxbiosciences.com.

About Quotient Sciences 
Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we save precious time and money in getting drugs to patients. Everything we do for our customers is driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast. Because humanity needs solutions, fast. For more information, visit quotientsciences.com.

The newly enhanced drug development platform will help empower innovators with the fastest[1] development timelines.

NOTTINGHAM (UK), February 17, 2022: Quotient Sciences – a global drug development and manufacturing accelerator offering a suite of services to clients in the pharmaceutical and biotech industry – announces that it has integrated drug substance into its flagship Translational Pharmaceutics® platform. The newly integrated service unites drug substance, drug product and clinical testing activities all within a unified organization and under a single project manager.

The full integration of drug substance R&D and manufacturing follows a year after the company’s acquisition of its Alnwick, UK site and provides a more streamlined approach from candidate selection through to commercialization. Quotient Sciences Translational Pharmaceutics® approach – combining manufacturing and clinical dosing at a single organization – enables innovators to adjust formulations and dosing in real time.

“Our Translational Pharmaceutics® platform is now in its 15th year and has accelerated development timelines for more than 500 drug programs. We remain the only outsourcing partner able to offer innovators the ability to manufacture, release, and dose under one organization. This approach is proven to shave 12-months off timelines and, by adding drug substance synthesis, the timeline from candidate selection to clinic can be further accelerated by 2-4 months,” commented Mark Egerton, CEO of Quotient Sciences.

Translational Pharmaceutics® was developed in consultation with the MHRA & FDA and employs a rapid “make-test” cycle, where drug products are manufactured, released, and dosed in a clinical study in days rather than months. This means biotechs and pharma companies can fast track molecules from First in Human (FIH) through Proof of Concept (POC).

“By fully integrating drug substance with drug product and clinical testing activities, Quotient Sciences can closely align manufacturing and dosing workflows, greatly improving R&D efficiencies, and increasing the potential for clinical and commercial success,” stated Peter Scholes, CSO of Quotient Sciences. “In fact, an independent study by the Tufts Center for the Study of Drug Development (CSDD) showed Translational Pharmaceutics delivered $200million in drug development cost savings per approved drug.”

“Our purpose has always been to bring new medicines to patients faster, and our new capabilities in drug substance continue to break down traditional industry silos. As we look to the future, Quotient will continue to bring on new services that further integrate drug development and streamline the outsourcing needs of our customers,” added Egerton.

For more information around our fully integrated Translational Pharmaceutics platform, click here.

Read the full release

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[1] https://www.quotientsciences.com/resources/assessing-financial-impact-translational-pharmaceu/

Quotient Sciences offers a work environment where we feel comfortable and motivated. The people and the culture have made this place a great place to work. 

-Faria Senjoti

Faria Senjoti, CMC Leader, started her career with us in 2020 as a Formulation Scientist. In this interview, she explains what she likes about the culture at Quotient Sciences.

Tell us about your current role – What does a CMC Leader do?

I am currently working as a CMC Lead at Quotient Sciences, Reading. My responsibilities include leading the formulation development project throughout project lifecycle. Besides supporting project set-up activities, I work with other formulation scientists and support them to develop the formulations at a development scale. I work on development plans and reports and communicate the technical progress to the clients. I work collaboratively with other teams (Manufacturing, Analytical, Material Management, Quality Assurance) to ensure smooth transition of programmes to GMP Operations for scale up and technology transfer.

What do you enjoy most about your role here and why?

In my current role, I enjoy working on diverse projects that help me enrich my technical skills. Because of working in a multifunctional team, there are always opportunities to learn and collaborate with colleagues. I feel that there are always opportunities to grow and progress within Quotient Sciences. I like that I am a part of a positive culture, where the contributions are valued and appreciated.

How has your career progressed at Quotient Sciences?

I had a fast career progression at Quotient Sciences. I started my career as a Formulation Scientist, then I was promoted to Formulation Scientist II. A few months after that, I was promoted to CMC lead. I believe if anyone would like to learn new things, is looking for opportunities to grow, and is open to feedback, Quotient Sciences is a place where they will be rewarded as I was through this career progression.

How do you describe Quotient Sciences as a place to work?

Quotient Sciences offers a work environment where we feel comfortable and motivated. The people and the culture have made this place a great place to work. There is always support available from colleagues no matter how challenging the situation.

Spotlight Interview with Harpreet Smith, Vice President & General Manager at our Miami, FL facility

Joining a great company like Quotient Sciences is a competitive effort on the part of new hires and we select only the top candidates to join our team.

-Harpeet Smith

What do you enjoy most about your role and why?

Knowing that we are helping to develop new medicines and get them to patients faster is exciting and very rewarding. What better mission can one have?

For any qualified candidates looking for a position at Quotient Sciences, what can they look forward to? 

Teamwork. Joining a great company like Quotient Sciences is a competitive effort on the part of new hires and we select only the top candidates to join our team. Team members can expect a collaborative and hands-on approach to delivering projects and a leadership team that encourages working together, driving for results, and operational excellence.

What else do you think differentiates Quotient Sciences from other drug development organizations?

Our clients rely on our expertise accelerate their drug development programs in a variety of ways. Uniquely, we provide both clinical pharmacology & research (CRO) services and pharmaceutical contract development & manufacturing (CDMO) services to the pharmaceutical and biotech industry. These services can be provided individually, or as an integrated service which has been shown to dramatically shorten development times, reduce outsourcing costs, and significantly simplify supply chains for customers.