Our streamlined approach to developing drug substance 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 manufacture. 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. We pride ourselves on quickly delivering high-purity drug substance and can rapidly scale up manufacture at our cutting-edge facilities.
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 in our purpose-built development and manufacturing facility.
Highly trained and experienced Quotient Sciences chemists support all aspects of drug substance development, selecting and developing optimum synthetic routes for drug substance manufacture. We combine rapid route selection with the implementation of innovative technological solutions to produce the shortest, most efficient 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 trial 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.
Quotient Sciences has extensive expertise in solid-form screening and selection, with material scientists working closely with drug substance chemists to identify the most appropriate drug substance form for development. Learn more about our pre-formulation and material science capabilities.
Our capabilities include:
Our facilities can provide both GMP (Good Manufacturing Practice) and non-GMP drug substance manufacturing, with the ability to generate kilogram-per-day quantities.
Our capabilities include:
At Quotient Sciences, we offer isotopic labeling services to 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. Our radiochemists have extensive chemical and radiochemical knowledge and experience of isotopically labeling hundreds of molecular entities. They work closely with our analytical and drug product teams to deliver a solution-focused service to our customers throughout all stages of drug development, from candidate development to commercial.
We are experts in the safe handling of 14C-labeled high-potency/high-hazard compounds (cytotoxics) and 14C-labeled gases and volatiles, including 14CO2. Our facilities are UK Medicines and Healthcare products Regulatory Agency (MHRA)-accredited, and we offer full GMP synthesis of 14C-labeled compounds for human studies.
For more information on our isotopic labeling capabilities, click here.
Quotient Sciences has access to scale-up and pilot plant assets that complement our on-site facilities, featuring a capacity range between 50 L and 1300 L capable of producing 5-100 kg in batch. Our internal manufacturing assets (batch, CSTR, trickle bed, and plug flow) range from multi-gram to multi-kilogram capacity (multi-tonne per annum capability). Additionally, our investment in innovative, flexible modular manufacturing technology enables us to quickly configure reactors for drug substance (API) manufacturing, then rapidly reassemble reactors for the next project.
Quotient Sciences can meet drug substance requirements from pre-clinical through to full-scale commercial phases. The scale-up process is executed by a highly experienced manufacturing team, providing customers with a secure source of supply for technically challenging projects.
Stability testing provides evidence of how time and changes in the environment affect the quality of a drug substance. At Quotient Sciences, 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.