Abstract: Presented at BioProcess International US West (BPI West) 2026, this session addresses the persistent challenges associated with difficult-to-express biologics, including bispecific antibodies and complex recombinant proteins, which often result in low titers, extended timelines, and scalability risks.

Abstract: Biopharma innovators face increasing pressure to advance monoclonal antibody programs to IND quickly without compromising product quality or downstream scalability.

Catalent has expanded its industry‑leading GPEx® Lightning platform to include HEK cell line development, creating a new standard for speed, expression control, and product quality in human-cell–based manufacturing.

Abstract: As the biopharma landscape grows more complex, Catalent works to ease the challenges of biologics development for its partners.

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This year, the long-awaited FDA draft guidance for Platform Technology Designation Program was launched.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.