Summary: Biotherapeutics are becoming increasingly sophisticated, often requiring the coordinated expression of multiple genes, processing enzymes, and cofactors.
Summary: Catalent’s SMARTag® Technology offers a versatile and innovative platform for the development of optimized antibody-drug conjugates (ADCs).
This year, the long-awaited FDA draft guidance for Platform Technology Designation Program was launched. This critical guidance allows drug developers to leverage Platform Technology data in approved drugs if similar “platforms” are used, accelerating the approval process and therapies to patients. In this webinar, George Buchman will discuss Catalent’s approach to platform processes as well as securing an integrated supply chain.
Summary: In a recent presentation during the 2024 JP Morgan Healthcare Conference, Catalent’s Group President of Biologics Dave McErlane addresses the latest market drivers for Biologics and Sterile Injectables.
Learn how Catalent took to a monoclonal antibody (mAb) from clinical to commercial phase under a highly compressed timeline.
In this webinar experts cover aspects of clinical trial design for orphan biologics products, key strategies for ensuring clinical trial supply throughout clinical development and the regulatory and legislative framework for delivery to patients.
