Drug Substance
Drug Substance
Quotient Sciences provides drug substance synthesis and manufacturing capabilities from candidate selection through to commercial production. With 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 substance has been shown to reduce manufacturing costs by 50% from preclinical to Phase I. To best support our customer’s 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 customer’s 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.
Our Drug Substance Services:
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 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-kg 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.
