Quotient Sciences understands the challenges associated with developing oncology drugs and has the expertise to successfully support biotech and pharmaceutical companies in accelerating development timelines from candidate selection through to commercial manufacture and supply.
As a fully-integrated manufacturing organization, Quotient Sciences is positioned to address the challenges associated with developing small molecule oncology therapeutics, supporting biotech and pharmaceutical companies in accelerating drug development timelines from candidate selection through to commercial manufacture and supply. Learn more about our capabilities in our latest whitepaper.
Pre-formulation assessment & formulation development
With unparalleled biopharmaceutics experience, we factor in and anticipate clinical considerations as well as the in vitro performance of pharmaceutical formulations. Early laboratory prototyping is performed on bench scale equipment in order to de-risk process scale-up and development should the molecule achieve its early clinical endpoints.
Clinical development & accelerating to POC
There are compelling drivers for small batch sizes, such as conservation of API, and dose flexibility in order to meet individual subject needs and reduced stability needs. Our experts provide the full spectrum of manufacturing and supply paradigms, from traditional large batch manufacturing, through bright stock distribution and personalized manufacturing.
Formulation optimization and validation of product performance in humans
Using Quotient Sciences' Translational Pharmaceutics platform, formulation flexibility in healthy volunteer trials can be used to develop “patient ready” formulations for oncology molecules in less than half the time of the industry standard. The integration of real-time manufacturing and clinical testing cycles enable formulation decisions to be made based on emerging human data.
Process development, scale-up & clinical manufacturing for Phase II/III
Recognizing the need to move rapidly through clinical development, we have the capability to efficiently scale-up drug product manufacturing processes from Phase I to meet the demands of later clinical trial requirements and ensure seamless transition to larger scale manufacturing and drug product commercialization.
Commercial manufacturing & supply
We work with our customers to configure a robust manufacturing and supply chain to meet their needs. We can accelerate development programs through registration and process validation and our manufacturing facilities support batch sizes ranging from less than 1 kg to over 500 kg for solid oral dosage forms and up to 350 L for liquid formats.
As a fully integrated drug development, clinical testing and manufacturing organization, Quotient Sciences addresses the challenges associated with developing small molecule oncology therapeutics. We are dedicated to accelerating the development of new drugs for patients around the world providing individual services or fully integrated programs through our unique Translational Pharmaceutics platform.
Connect with us today to learn how we can help support the development and manufacturing needs of your oncology drug program.