Dr. Sarah Stevens, former VP of Drug Development Sciences at Quotient Sciences, discusses the recent acquisition of Arcinova and the integration of drug substance, drug product, and clinical testing capabilities in a Drug Development & Delivery Special Feature Report, "Outsourcing Formulation Development & Manufacturing: Meeting Demand for Biologics & Specialty Drugs"

For the past decade, Quotient Sci­ences has created a delivery platform that integrates drug product and clin­ical testing activities to achieve pro­gram acceleration. To support this further, Quotient Sciences recently acquired Ar­cinova, the UK-based CDMO, be­cause of its expertise and capability in early-stage drug substance and bio­analysis work.

"We see a great opportunity for investing in and integrating drug sub­stance services into our existing drug product and clinical testing platform," says Sarah Stevens, Vice President of Drug Development Sciences, Quotient Sciences.

Drug substance manufacturing often sits on the critical path in early development with drug product man­ufacturing and clinical trial initiation routinely suffering from late API sup­ply, she says. As one of the major causes of project delays, it is important for biotech companies to work closely with API manufacturers early in the de­velopment process to ensure the drug substance is not only supplied on time but that potential formulation or downstream challenges have also been identified or flagged up front.

"The investment in this capability will enable the integration of drug substance, drug product, and clinical testing capabilities – all under one or­ganization with a single Project Man­agement function," she says.

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Quotient Sciences (formerly Arcinova) recently completed the purchase and installation of a new system that doubles capacity in GC-MS and expands analytical capabilities.  

The Thermo Scientific™ TSQ™ Duo triple quadrupole GC-MS/MS system recently installed at Quotient Sciences - Alnwick (formerly Arcinova) is tailored to chromatographers and single quadrupole GC-MS users who need easy access to powerful new workflows through MS/MS and the ability to meet current method requirements. It features selected reaction monitoring (SRM) to cut through heavy matrix backgrounds for clear detection of target compounds, and configurable headspace and liquid injection that allows for a variety of GC and GC-MS applications. Additionally, this system features intelligent functionality that supports increased efficiency in our laboratories.

Quotient Sciences - Alnwick (formerly Arcinova) is equipped with other technologies including an Agilent GC-MS with EI/CI Source and GERSTEL multi-purpose sampler with liquid and headspace capacity, providing us with extra capability when working with small volatile molecules.

Stuart McDougall, Bioanalysis Leader at Quotient Sciences (formerly Arcinova), said of the added capabilities: “We are continuing to invest in state-of-the-art equipment to match our world-class capabilities and expertise, and this new system will play a key part in the expansion of our GC-MS services in Alnwick."

Quotient Sciences announces a significant expansion to its operations in the U.S. with the opening of a state-of-the-art, 45,000-square-foot facility located near Philadelphia, in Garnet Valley, Pa. 

$15 million investment creates a center of excellence for early-phase formulation development and clinical trial manufacturing.

The Garnet Valley site will focus on developing small-molecule oral drug products, supporting development programs from the preclinical stage through to clinical proof-of-concept. Seamless scale-up to late-phase manufacturing and commercial product supply will continue at Quotient’s nearby Chelsea Parkway facility.

“Our new facility was built in response to increasing customer demand for our early-phase formulation development and clinical trial manufacturing services,” said Mark Egerton, Ph.D., CEO of Quotient Sciences. “The site was specifically designed to optimize our ability to work with highly potent and poorly soluble molecules that dominate the industry pipeline.”

“The facility also increases our capacity to provide integrated Translational Pharmaceutics® programs in the U.S., which deliver substantial benefits to customers including cost savings and reduced timelines to achieve proof-of-concept,” Egerton added.

The expanded formulation development, analytical, and manufacturing capabilities enable biotech and pharmaceutical companies to access Translational Pharmaceutics programs working under an investigational new drug (IND) application. This approach integrates real-time adaptive manufacturing and clinical research. Drug products manufactured at the Garnet Valley facility can be rapidly supplied to global patient trials and clinical pharmacology units, using tailored batch sizes and flexible dose adjustments.

Quotient Sciences has comprehensive drug product expertise spanning all dosage forms, from liquids to solids, immediate-release to modified-release, and solubilization technologies including spray-dried dispersions, micronized and lipidic formulations. The new facility is also designed to handle both potent and non-potent products, with six high-potency GMP manufacturing suites.

A further expansion of Quotient Sciences' formulation and manufacturing operations will be announced in the coming months. 

Nottingham, U.K., November 5th, 2018 – Quotient Sciences, a leading drug development services organization, has significantly expanded its formulation development and clinical trial manufacturing operations at its Reading, U.K., facility. The program’s investment has tripled the site’s GMP capacity, added new equipment for solid oral dose manufacturing, and significantly increased staffing levels.

“Our investment in Reading is in direct response to increasing client demand,” said Mark Egerton, CEO of Quotient Sciences. “With drug development expertise on both sides of the Atlantic, we are optimally positioned to serve our global client base. The Reading site can support customers with stand-alone formulation and clinical trial manufacturing services that can also be integrated into Translational Pharmaceutics^® programs.”

Activities at the 48,000-square-foot Reading facility are focused on small molecule drug products for oral and inhaled delivery spanning drug substance characterization, formulation development, and clinical trial manufacturing. The site routinely handles poorly soluble compounds and is equipped with a broad range of technologies including spray drying, hot melt extrusion, lipidic systems, and micronization.

Its capacity is bolstered by 13 GMP manufacturing suites to support traditional Phase I-III clinical trial manufacturing and Translational Pharmaceutics programs that integrate real-time adaptive manufacturing and clinical research. This flexible and nimble approach allows batch sizes to be tailored to the precise needs of a clinical trial. Drug products are rapidly supplied to global patient trials and clinical pharmacology units, delivering substantial benefits to customers including flexible dose adjustments, reductions in manufacturing costs, and shorter manufacturing lead times.

Quotient Sciences has more than 800 employees across six operating sites in the U.K. and U.S., serving a global customer base of more than 150 biotech and pharma clients.

Nottingham, U.K., December 3rd, 2018 - Quotient Sciences, a leading drug development services organization, has invested in additional spray drying capabilities at its formulation development and clinical trial manufacturing facility in Garnet Valley, PA.

In this latest U.S. expansion, Quotient Sciences has completed the installation of a GEA Niro Mobile Minor™ unit to support the rapid development of solid dispersions and clinical production of batches sizes up to 10 kg.

Over the past 20 years, Quotient Sciences has built a strong reputation for addressing complex solubility and bioavailability challenges with a range of formulation technologies including spray drying, hot melt extrusion, lipidic systems, and micronization. Small-scale and pilot-scale spray drying has been a core capability in the Company's portfolio of services in the U.K. and in 2017, the company established spray drying in the U.S. with the installation of a ProCepT spray dryer.   

“Our investment in spray drying is in direct response to increasing client demand and the prevalence of poorly soluble molecules in their drug development pipelines,” said Mark Egerton, CEO of Quotient Sciences. “With spray drying expertise on both sides of the Atlantic, we’re now able to seamlessly support our global client base as they transition from preclinical to proof-of-concept patient trials.”

The 45,000-square-foot Garnet Valley site is a hub for early-phase formulation development and clinical trial manufacturing. The facility was designed to handle highly potent products with six high-potency GMP manufacturing suites. Quotient Sciences' expertise in handling highly potent molecules encompasses more than 300 Category 3 - 5 compounds across its manufacturing sites.

Globally, Quotient Sciences has more than 800 employees across six operating sites in the U.K. and U.S., serving a global customer base of more than 150 biotech and pharma clients.

Quotient Sciences and global investment firm Permira today announced that a company backed by the Permira Funds has signed a definitive agreement to acquire a majority stake in Quotient Sciences from companies controlled by GHO Capital and other investors for an undisclosed sum. 

The investment provides substantial new funding to fuel the next stage of Quotient Sciences' growth. Chief Executive Officer Mark Egerton and the management team will continue to lead Quotient Sciences.

Quotient Sciences has brought innovation to the pharmaceutical services sector through its unique Translational Pharmaceutics® platform, which is proven to accelerate development timelines, reduce development costs, and drive improvement in R&D productivity. The business has experienced substantial growth over recent years and generates annual revenues in excess of £100 million.

“We are delighted to partner with Permira to drive Quotient Sciences through our continued evolution,” said Mark Egerton, Ph.D., Chief Executive Officer of Quotient Sciences. “The investment by the Permira Funds will support Quotient’s continued growth plans, which include broadening our core services portfolio and expanding our formulation development and manufacturing capabilities to meet the demands of our growing customer base.”

Marcel Lacaze, Principal in the Global Healthcare Group of Permira based in London, added, “Quotient Sciences and its disruptive approach to pharmaceutical drug development have created a truly unique business model. With GHO’s support, the business has developed strongly in recent years and we look forward to partnering with Mark and his team in continuing to grow this exciting company.”

The Partners at GHO Capital have enjoyed working with the Quotient Sciences team since 2015. “During this period, the business has achieved a global footprint, replicated its unique Translational Pharmaceutics in the U.S., and validated itself as a commercial drug product manufacturer. Having more than doubled its capacity and made large investments in operational infrastructure, Quotient Sciences is well placed to continue its strong performance, and we look forward to seeing their continued success in partnership with Permira.”

Quotient Sciences (formerly Arcinova) was announced as a winner of the 2020 CPhI Pharma Award for Excellence in Pharma. The Company was recognized for innovation for the Quotient Sciences FlowInova project, a collaboration with the University of Nottingham on a continuous drug substance manufacturing platform. The platform offers a more sustainable and less wasteful manufacturing approach that can significantly reduce the time and cost associated with new drug development.

The annual awards are held as part of the CPhI Europe tradeshow.

Congratulations to all of the other winners and shortlisted companies, and thank you to the judges for selecting us for this recognition.

Quotient Sciences (formerly Arcinova) completes installation of the Sciex 6600 T-TOF system equipped with an Exion LC front end and Sciex BioTool software, increasing LC-MS capacity.

With these tools, the Company adds capacity for not only the quantitation, confirmation, and characterization of large biological molecules. Unlike other mass spectrometer systems on site, this system allows for the rapid characterization of the intact masses of large biological molecules and at the same time can accurately quantify them in difficult matrices. 

This type of instrument is increasingly in demand across the pharma and biotech industry as clients with new biological entities, such as antibody-drug conjugates, seek answers to increasingly complex analytical problems.

The Sciex 6600 T-TOF system can also be used for routine quantitation of molecules, increasing the Company's bioanalytical capacity for clients. The combination of this system with BioTool and other software platforms and online databases allows for the identification and confirmation of proteins in sample mixtures.

Quotient Sciences has been recognized as a “Top Pharma and Life Sciences Outsourcing Services Company in the UK for 2020” by PharmaTech Outlook magazine.

Quotient Sciences won this award in recognition of our integrated approaches to drug development, exemplified by our Translational Pharmaceutics® platform. This recognition was awarded to only five companies that are considered to be at the forefront of providing pharmaceutical and life science outsourcing solutions and transforming businesses. 

Pharma Tech Outlook is a major print magazine that provides insight into design, development, manufacture, evaluation and dosage of drug delivery system including breakthroughs in pharmaceutical infrastructure, tools and equipment to their readership.

Accompanying the award is an article in which Matt Paterson, Vice President of Strategic Marketing, shares the background on Quotient Sciences and how we help customers make their drug development processes more efficient and get new molecules to patients faster.

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Quotient Sciences (formerly Arcinova) has recently taken delivery and commissioned the award-winning R1000 Robotic Capsule Filler from life-sciences automation company 3P Innovation. 

Technology investments increase the UK’s capacity to manufacture small-molecule and high-potency medicines, with patients set to benefit from accelerated access to targeted drug therapies.

The R1000 includes 3P’s award-winning, patented Fill2Weight micro-dosing technology, which directly supports the optimization of drug substance through direct filling into capsules. With its capability of handling challenging powders with poor flow properties, Fill2Weight enables formulators to bypass the need for excipients, with the associated benefit of avoiding the need for excipient compatibility tests. The result is a significantly faster route through clinical trials and lower overall costs.   

Quotient Sciences' (formerly Arcinova) previous manufacturing method for patient-specific drug products involved a non-automated procedure with a production rate limited to 200 units per hour. The installation and commissioning of the new state-of-the-art robotic machine from 3P Innovation increase production to 1000 units per hour, while maintaining the same level of operator labor. The fully automated capsule filler gives the Company an agile manufacturing solution with traceable weight recordings for each capsule.

The installation of this equipment is part of a multi-million-pound investment in the Alnwick, UK facility that aims to create a more responsive approach to producing complex medicines in smaller volumes. Employing digital technologies with automation and machine learning, the Company can produce on-demand therapies for small patient populations. 

Stephen Byard, Head of Drug Product at Quotient Sciences - Alnwick (formerly Arcinova) said, “Through continued investment in people and advanced instrumentation, we have reliably expanded service lines to satisfy the increased demands of progressing new medicines through to the clinic faster, without compromising quality." said Stephen Byard, from Quotient Sciences. 

Gareth Jenkins, Chief Scientific Officer at Quotient Sciences - Alnwick (formerly Arcinova) added, “Our vision is to improve patient care through transformational technology. We are excited to see our digital medicines manufacturing platform become operational, putting a vision of just-in-time clinical supply one step closer to reality.”