Accelerate the development of your oncology drug candidate

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.