How can I accelerate the development of my oncology drug candidate?

1. 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. We emphasize the importance of data driven decisions in early development and prioritize the key API characterization data required. This 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). 

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

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, 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.

5. Commercial manufacturing & supply

We work with our customers to configure a robust manufacturing and supply chain to meet their needs. Our investments in small-scale commercial equipment have allowed us 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, we have the expertise to manufacture your registration and validation batches. Additionally, our experienced team has significant experience of supporting 505(b)(2) and all post-approval change filings.