At the point of selecting a lead compound for a drug development program, the supply of drug substance is on the critical path and required for all downstream activities.

To ensure that the drug program progresses efficiently, process development must enable safe, economical, and rapid scale-up of drug substance manufacturing. Drug developers require service providers with extensive chemistry capabilities, who are focused on the timely delivery of material and who can deliver drug substance manufacturing processes that can be scaled up at minimum risk.

Quotient Sciences is a drug development accelerator, offering contract development, research, and manufacturing services to pharma and biotech companies worldwide. We pride ourselves on quickly delivering high-purity drug substances and can rapidly scale up manufacturing at our cutting-edge facility. With more than 40 years of experience in synthetic organic chemistry and extensive expertise in flow chemistry, synthetic biology, and biocatalysis, we can optimize manufacturing processes and save months of development time for our customers.

Learn more about our capabilities in our latest whitepaper.

A core component of Quotient Sciences is our integrated capabilities in drug substance process research, development, and manufacturing. All are carried out at our state-of-the-art facility in Alnwick, UK.

Quotient Sciences and Astrazeneca Co-Authored Scientific Publication evaluating Savolitinib in healthy male volunteers.

Assessing how your drug interacts with other drugs in vivo is a critical step in the drug development process and is essential in ensuring safe and efficacious drug delivery. This assessment is known as a drug-drug interaction (DDI) study and is a regulatory requirement for submissions of investigational new drugs (INDs). Learn more about Quotient Sciences' offering for these studies.

In May 2022, the FDA announced new draft guidance on Human Mass Balance Studies​. Dr. Adam Robinson-Miller, Senior Manager 14C Enabled Drug Development at Quotient Sciences, shares his thoughts on their impact and clinical pharmacology considerations. Watch his presentation below and request a copy of the poster for added insight.

In this whitepaper, Quotient Sciences highlights the key challenges that arise in pediatric formulation development, offers potential solutions, and discusses future trends and regulatory aspects that can help streamline pediatric medicines to patients faster.

On Demand Webinar

Summary
The drug development process has been demonstrated to be extremely costly, lengthy, and risky with significant rates of molecule attrition. Despite long-standing efforts by drug developers to operate more efficiently, traditional drug development programs have become costlier on average.

To inform drug developers of the potential financial impacts of alternative drug development processes and outsourcing models, the Tufts CSDD conducted a study comparing traditional drug development programs to Quotient Sciences’ signature drug product manufacturing and clinical testing platform, referred to as Translational Pharmaceutics.

Translational Pharmaceutics is a unique platform that integrates formulation development, manufacturing, and clinical testing and has been widely used by pharmaceutical and biotech companies to accelerate product development across the full development cycle.

Key applications of Translational Pharmaceutics include the transition of molecules from First in Human (FIH) to Proof of Concept (POC), and in the development and optimization of clinical formulations including modified release (MR) drug products and solubility-enhanced dosage forms.

This webinar summarizes the key findings of the Tufts CSDD research on Translational Pharmaceutics, which includes mean time savings of >12 months and financial gains of >$100 million per drug approved.

Key Learning Objectives

• Discover the difference between Translational Pharmaceutics and traditional approaches to drug development. 
• Realise the multi-million dollar benefits of Translational Pharmaceutics, as demonstrated in the Tufts CSDD study.
• Learn how much time and budget you could save on your drug development timeline.
• Uncover the findings of the Tufts CSDD study including a review of the methodology, results, and key conclusions.
• Hear from real case studies that demonstrate how Translational Pharmaceutics can be utilized during drug development.

Hear strategies being used by biotech and pharmaceutical companies to overcome biopharmaceutic challenges for small molecules in today's drug development pipeline.

Chris Roe, Principal Research Fellow at Quotient Sciences, discusses effective strategies to overcome biopharmaceutic challenges for small molecules and alternative approaches for accelerating your early development plan. He presents case studies related to poorly soluble molecules, drugs with short half-lives, and preclinical to clinical translation.

Summary

Nominated candidates entering clinical development often have sub-optimal physicochemical, biopharmaceutic or DMPK properties for oral delivery. Development teams are challenged with how to understand the properties of new drug candidates, how to design the appropriate formulation strategy, and how to move quickly and successfully into early-phase clinical trials. Along the way, it is important to identify developability risks and take steps to mitigate these factors, balanced carefully against time and cost investments.

Key Points:

• The importance of salt and polymorph screening and prototype selection for pre-clinical assessment
• BCS or DCS assignment and developing a formulation strategy for poorly soluble molecules
• The role of physiologically based pharmacokinetic (PBPK) modelling and simulation (M&S) for rational formulation design
• Teasing apart the drivers of poor bioavailability - In-vitro testing / in-silico techniques / in-vivo preclinical studies / clinical assessment
• Choosing the appropriate dosage form for first-in-human trials
• Formulation optimization using adaptive clinical programs

Learn about specialized modified-release formulation technologies that are available in the drug development “toolbox” to achieve an optimal target product profile.

In this webinar, Dr. Vanessa Zann, Senior Drug Development Consultant at Quotient Sciences, uses case studies to describe the specialized formulation technologies that are available to achieve an optimal target product profile and how adaptive clinical programs can use human PK data to optimize modified release formulation compositions in real time.

Presentation Overview

Oral modified-release drug products remain highly prevalent in drug development pipelines. These dosage forms tailor the in vivo drug release profile to achieve improved therapeutic outcomes for drugs intended for both local (gastrointestinal) action and systemic delivery. Patients with chronic and acute conditions benefit from the use of modified-release dosage forms given that they offer greater compliance and less frequent dosing regimens, coupled with potentially greater efficacy and fewer side effects in comparison to immediate-release delivery systems.

Many modified release technologies are available to drug developers, each designed to fulfill very specific performance requirements, such as gastro-retention or sustained-, pulsatile-, or delayed-release formats. The design and development of an effective modified release formulation is however an inherently complex process, presenting many challenges for the development team. Human gastrointestinal anatomy and physiology strongly influence drug release and performance of modified release dosage forms given regional variations in pH, fluid volumes and compositions, surface area, metabolizing enzymes, and membrane transporters. Challenges are exacerbated by an over-reliance on in vitro and preclinical test results to inform formulation prototype selection, despite evidence that these data often correlate poorly with pharmacokinetic (PK) performance in humans.

Key Points

• What challenges exist when developing and manufacturing modified-release formulations
• What drives the need and what are the benefits when going from immediate release to modified release
• Which approaches to deploy in modified release formulation, such as matrix vs. multiparticulates
• What relationships exist between formulation parameters, in vitro data and in vivo performance
• How gamma scintigraphy can be used to understand bioavailability
• How to evaluate and optimize formulation performance in real-time using clinical data and design spaces

Our Expert

Dr. Vanessa Zann is a Senior Drug Development Consultant at Quotient Sciences. Vanessa has over two decades of industry experience providing biopharmaceutical support to discovery, development, and clinical programs.

Meet Our Expert

Learn about drug substance and formulation considerations that can help improve downstream clinical outcomes.

Navigating the small molecule CMC pathway from discovery to the clinic comes with challenges and regulatory hurdles. Once the lead candidate has been selected to move into development, what’s next?

With the stakes high, having trusted and experienced guidance at this stage can help streamline the pathway from discovery to IND, reduce risk, and improve the likelihood of clinical success. Consulting group NGT BioPharm Consultants and Quotient Sciences has helped hundreds of customers achieve their IND milestones and beyond.

Overview

Bridging from discovery and clinical development can present many questions and unknown challenges for drug developers, such as:

• What are some of the drug substance, drug product, and clinical supply considerations in advancing a drug candidate toward a First-in-Human study?
• Would an integrated drug substance and drug development approach be best for a clinical program?
• How long does each critical step take before reaching the clinic?
• What regulatory considerations does one need to be aware of?

By offering strategic guidance and integrated services spanning the entire development pathway, both companies have supported programs with lead candidate selection, drug substance, drug development, biopharmaceutics, clinical and regulatory services, all focused on accelerating development and expediting strategies to address regulatory expectations toward clinical development.

Our featured speakers share their expertise around the challenges and considerations that drug developers may face in early development, and present case studies that demonstrate the benefits of an integrated drug substance and drug product approach.

• Get insight into the timeline for each stage of the development process
• Hear the benefits of an integrated approach to accelerate from candidate selection and onward into the clinic
• Learn about regulatory challenges to be aware of when bridging from candidate selection to IND and beyond 

In Partnership With

NGT BioPharma Consultants

Featured Speakers

• Eleanor Row, Executive Director, Quotient Sciences
• Mark A. Krook, Head, Early Development, NGT BioPharma Consultants
• Roger Nosal, Head of Regulatory Strategy, NGT BioPharma Consultants

Learn from Michael Blackburn, Head of Bioanalytical Method Development and Labs, how our physiochemical-based approach enables us to accelerate the development of bioanalytical assays for insulin analogues.

Insulin analogues, along with other large peptides, such as GLP-1 receptor agonists, represent a major and growing class of biotherapeutics. Their quantification plays an important part in improving the outcome of downstream formulation development and clinical study activities. However, there are sensitivity challenges when trying to measure trace levels of these types of compounds which require advanced technologies such as LC-MS.

Presentation Overview

In this presentation, Michael Blackburn, Head of Method Development and Labs, will describe the bioanalytical strategy that Quotient Sciences employs to best support clinical trials for these compounds and how our physiochemical-based approach enables us to accelerate the development of bioanalytical assays for insulin analogues.

Through case studies, our speaker will touch on some of the pitfalls and solutions that our team of experts have encountered in this field and share what scientists should be aware of when interpreting how LC-MS data correlates with immunoassay data. Using assay validation data, we will cover high-throughput sample analysis and the potential impact of anti-drug antibody effects.

Key Topics

• How a physiochemical-based approach allows for enhanced specificity and ease of multiplexing, with no requirement for a specific antibody.
• Key considerations that scientists must be aware of in order to meet the demanding requirements for high-throughput analysis of insulin by LC–MS.
• The important role that advanced LC-MS technology plays
• LC-MS vs Immunoassay Data and Considerations around free or total peptides
• Bioanalytical assay acceptance criteria & antidrug antibody effects during drug development