Engaging a contract development and manufacturing organization (CDMO) and outsourcing certain activities can accelerate process development and manufacturing by taking advantage of added expertise and capacity. However, the decision to outsource must be carefully made, evaluating the benefits and risks.
Teva Pharmaceuticals worked with Cytiva’s Fast Trak™ team for the transfer and scale-up of one of their biologics manufacturing processes.
Teva began with a strong manufacturing process on a single-use platform. Their goal was to establish consistent performance at scale-up compared to an existing lower scale process. Achieving this required process knowledge and experience with the cell type and expression system.
This article presents the partnership and a successful tech transfer based on effective communication, conscientious project management, and widespread technical and regulatory expertise.