Summary: Learn about the major achievements in the gene therapy market in 2023, with a focus on reliable manufacturing processes and strategies to enhance predictability while reducing waste in gene therapy manufacturing.

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.

Here we present an in-line cell lysis assembly developed at Catalent to increase throughput while controlling critical parameters such as time of contact and solutions ratio, delivering a high-quality product.

This webinar explored the challenges of cell therapy manufacturing and introduced Catalent's UpTempo CAR-T Platform process as a solution.

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, Catalent's experts detail a scalable approach to fast-tracking AAVs with integrated solutions, from clonal cell-lines to market.

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.

In this article, Catalent explores protein variants, focusing on charged variants, by outlining their impact on protein-based drugs, and explain how specific characterization techniques can be used to determine product safety and efficacy.

In this presentation, the development of a cell-based potency assay on an automated platform is discussed.

Summary: Catalent Biologics provides characterization and GMP support for a full spectrum of biologics including advanced modalities, such as cell and gene therapies, mRNA, and antibody-drug conjugates (ADCs).