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.
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.
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 preformulation and material sciences capabilities.
Our facilities can provide both GMP and non-GMP drug substance manufacturing with the ability to generate kg per day quantities.
Our capabilities include:
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 multigram to multikilogram capacity (multitonne p.a 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 preclinical 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 materials 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.