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1. Pre-Formulation Assessment & Formulation Development
At Quotient, we emphasize the importance of data driven decisions in early development. Quotient prioritizes the key API characterization data required, which allows our scientific experts to recommend selection of the appropriate API form as well as informing a data-driven strategy for preclinical and clinical pharmaceutical development based on the Developability Classification System (DCS). 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, which mirror both small scale and mid to-large scale GMP manufacturing, in order to de-risk process scale-up and development should the molecule achieve its early clinical endpoints.
2. Clinical development: accelerating to POC
Our experts provide the full spectrum of manufacturing and supply paradigms, from traditional large batch manufacturing, through bright stock distribution and personalized manufacturing. 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. Fundamentally, with personalized manufacturing, the product is made on-demand, only when needed based on patient requirements. Overall, this alternative approach offers a reduction in waste and cost, while maximizing the potential for clinical success.
3. Formulation optimization and validation of product performance in humans
At Quotient Sciences, we have demonstrated that 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. This is accomplished by the close integration of real-time manufacturing and clinical testing, also known as Translational Pharmaceutics, which uses a 14-day “make-test” cycle, enabling formulation decisions to be made based on emerging human data.
4. Process development, “scale-up” & clinical manufacturing for Phase II/III
Recognizing the need to move rapidly through clinical development, Quotient has 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.
5. Commercial manufacturing & supply
At Quotient, we work with our customers to configure a robust manufacturing and supply chain to meet their needs. We continue to invest in small-scale commercial equipment to broaden the technologies and product formats available and ensure seamless continuity throughout the development life cycle. 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. Whether you are preparing for ANDA, NDA, MAA or Japanese NDA, Quotient has the expertise and regulatory approval to manufacture your registration and validation batches for the U.S., U.K., Europe and Japan. The Quotient team also has significant experience of supporting 505(b)(2) and all post-approval change filings.
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 by clicking here.