Outsourcing Your Highly Potent Oncology Drug Product

Precision targeted immunotherapies that are tailored specifically to their disease are transforming patient treatment in oncology. Advances in the molecular understanding of cancer, coupled to regulatory support to get novel treatments to market quickly, are leading to the development and approval of powerful targeted therapies that are capable of causing the complete and durable elimination of tumors. However, targeted cancer treatments present formulation challenges, and their highly potent classification necessitates specialized facilities, equipment, and contained processing technologies for manufacturing and packaging. Many biopharmaceutical companies aiming to overcome these challenging processing requirements will look to outsourcing partners for the manufacture and packaging of their oncology drug products.

Specialist contract development and manufacturing organizations (CDMOs) with experience in highly potent processing and expert containment solutions offer a breadth of expertise that may not always exist within biopharmaceutical companies. Assessing a CDMO’s capabilities, track record, compliance history, and ability to provide long-term support is critical to the success of any outsourcing decision. The additional formulation challenges and rigorous regulatory process involved in processing HPAPIs makes this decision even more important. Conducting due diligence to identify a specialist CDMO with safe, scalable, and flexible processes capable of expanding commercial manufacturing to meet anticipated peak demands will be key to getting your oncology drug to market quickly.