Accelerating Peptide Development: Strategies to optimize the formulation and manufacture of peptide therapeuticsRegister here
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 40years 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 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’s 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 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. For more information on our preformulation and material sciences capabilities, click here.
Our facilities can provide both GMP and non-GMP drug substance manufacturing with the ability to generate kg per day quantities.
Current capabilities include:
Quotient has access to additional scale up and pilot plant assets to complement our on-site facilities with a capacity range between 50 L and 1300 L capable of producing 5-100 kg in batch. We have a range of internal manufacturing assets (batch, CSTR, trickle bed and plug flow) from multigram to multikilogram capacity (multitonne p.a capability).
The combined offering allows Quotient to meet our customer’s drug substance requirements from preclinical through to full scale commercial phases. The scale up process is executed by a highly experienced manufacturing team, providing our customers with a secure source of supply for technically challenging projects.
Our investment in innovative and flexible modular manufacturing technology will further enhance our capabilities. The technology enables us to quickly configure reactors for drug substance (API) manufacture and then rapidly reassemble reactors for the next project.
Stability testing provides evidence of how time and changes in the environment affect the quality of a drug substance. It is used to establish a re-test period for the drug substance and to determine the most suitable conditions for storage.
At Quotient, 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.