An experienced, flexible drug product development and manufacturing partner.
At Quotient Sciences, we emphasize the importance of data-driven decisions in early development. We prioritize the key API characterization data required, which allows our scientific experts to recommend the selection of the appropriate API form as well as inform a data-driven strategy for preclinical and clinical pharmaceutical development based on the Developability Classification System (DCS). With unparalleled biopharmaceutical 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 mirrors both small-scale and mid-to-large-scale GMP manufacturing, to de-risk process scale-up and development should the molecule achieve its early clinical endpoints.
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 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.
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.
Recognizing the need to move rapidly through clinical development, we can efficiently scale up drug product manufacturing processes from Phase I to meet the demands of later clinical trial requirements and ensure a seamless transition to larger-scale manufacturing and drug product commercialization.
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 Sciences has the expertise and regulatory approval to manufacture your registration and validation batches for the U.S., U.K., Europe, and Japan. Our expert team also has significant experience in supporting 505(b)(2) and all post-approval change filings.