Abstract: Catalent’s GPEx® Lightning platform accelerates stable cell line development for complex biologics by combining high‑titer expression, tunable performance across modalities, and proven scalability from small‑scale to GMP production.

Catalent Biologics’ Limoges, France development center is our European center of excellence for early phase clinical biologics formulation development and drug product fill/finish.

Cell-based assays play a critical role in assessing potency for traditional biologics and advanced therapeutics. For all analytical methods, increasing accuracy and precision while decreasing variability are critical to optimizing a method. For a cell-based assay, due to their biologic nature, the variable material inputs provide a challenge.

Cell-based assays play a critical role in assessing potency for traditional biologics and advanced therapeutics. For all analytical methods, increasing accuracy and precision while decreasing variability are critical to optimizing a method. For a cell-based assay, due to their biologic nature, the variable material inputs provide a challenge.

Summary: Learn how Catalent’s formulation development and integrated manufacturing services can help EBPs through the complexities of the drug development process.

Summary: Catalent Biologics provides comprehensive services to meet complex biologic development needs. Click to see our global locations and services...

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.

In this article, experts provide an overview of current challenges associated with high-concentration protein formulations and in formulating mRNA lipid nanoparticles (mRNA-LNP) and how to overcome them.

Watch this expert panel discussing the increased emphasis on risk management and contamination control strategies across the industry.

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.