Drug Substance Development & Manufacturing
Reduce drug substance manufacturing costs by 50% from pre-clinical to Phase I
Quotient Sciences provides drug substance synthesis and manufacturing capabilities from candidate selection through to commercial production. With our tactical deployment of best-in-class technologies, we minimize chemistry costs and move your drug substance supply off the critical path.
Our streamlined approach to developing drug substances has been shown to reduce manufacturing costs by 50% from pre-clinical to Phase I. To best support our customers' needs, we have made significant investments in technologies and equipment to meet the increasing demand for complex small-scale drug substance manufacturing.
Bringing four decades of experience to optimize drug substance manufacturing processes
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, coupled with 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 whitepaper, The First Kilograms of GMP Drug Substance.
Now Open: New Drug Substance Facility in Alnwick, UK
A £6-million state-of-the-art building expansion of our Alnwick, UK, facility delivers comprehensive, integrated support for customers bridging from candidate selection to early clinical development and beyond. The newly expanded space features multi-purpose capacity of up to 15 GMP reactor streams with reactor volumes ranging from 5 liters up to 150 liters and deployment of both batch or continuous flow chemistry technologies.
Move your drug substance supply off the critical path
Our highly experienced chemistry, analytical, and drug development teams can support route selection, process development, critical process parameter (CPP) definition, experimental design (DoE), and impurity tracking/control, as well as developing bespoke and innovative solutions for our customers' technically difficult challenges.
We always strive to produce economical processes for high-purity drug substances that can be rapidly scaled from grams to multi-kilograms. Core components of our integrated offering include capabilities in drug substance process research, development, and manufacturing, all carried out at our state-of-the-art facility in Alnwick, UK.
Drug Substance Services from Quotient Sciences
Process Research and Development
Highly trained and experienced Quotient Sciences chemists support all aspects of drug substance development, selecting and developing optimum synthetic routes for drug substance manufacturing also known as API manufacturing (Active Pharmaceutical Ingredient).
We combine rapid route selection with the implementation of innovative technological solutions to produce the shortest, most efficient and most scalable pathway to a drug substance. Our focus is on process velocity and economy, product purity, process scalability, and safety. The drug substance can then be scaled to multi-kilogram quantities to support direct client supply, or as part of an integrated in-house drug substance/drug product package to support clinical trials or full-scale commercialization programs.
Quotient Sciences' philosophy targets optimal velocity for drug substance delivery, to ensure rapid drug substance supply for urgent clinical trial needs while enhancing process efficiency and robustness to lower costs and generate higher purity. Our work also involves defining the best route for product manufacturing scalability.
Solid-State Services
Our expertise in solid-form screening and selection, with material scientists working closely with drug substance chemists, can help to identify the most appropriate drug substance form for development.
GMP & Non-GMP Manufacturing
Our facilities can provide both GMP (Good Manufacturing Practice) and non-GMP drug substance manufacturing, with the ability to generate kilogram-per-day quantities. Additionally, we have access to scale-up and pilot plant assets that complement our on-site facilities, with a capacity range between 50 L and 1300 L capable of producing 5-100 kg in batch.
Stability Testing
Stability testing provides evidence of how time and changes in the environment affect the quality of a drug substance. We produce high-quality stability data through a combination of analytical, microbiological, and material science methodologies. Our service is supported by state-of-the-art facilities, including walk-in, ICH-compliant stability chambers and several smaller, reach-in units. ICH-compliant photo-stability testing equipment is also available to study the effects of light stress on materials and packaging.
Isotopic Labeling
Get secure and rapid delivery of isotopically labeled (14C/stable isotope labeled) materials to support your non-clinical and clinical development.
Our isotopic labeling services support 14C human ADME studies and stable isotope labeling (SIL) for studying development candidates. Our team of experts provide guidance on the design and conduct of both non-clinical and clinical human ADME studies for research, development, and regulatory purposes. Through the use of mass spectrometry, our highly trained chemists are able to provide highly accurate measurements of test substances that aid in candidate development.
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WhitepaperThe First Kilograms of GMP Drug SubstanceA 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.
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Info SheetDrug Substance Synthesis and ManufacturingTactical deployment of best-in-class synthesis technologies to minimize chemistry costs and move your drug substance supply off the critical path.
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Case StudiesThermal Rearrangement - Flow Chemistry Case StudyQuotient Sciences seeking to improve the yield and purity of a US Biotech API intermediate using flow chemistry
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Case StudiesAPI Development Case StudyRapid development of a scalable route towards an analogue of a new drug substance, with definition of an optimal salt form for formulation