Watch this webinar to learn how Quality by Design (QbD) transforms biologics manufacturing by focusing on process understanding and design control.

In this episode of “The Top Line”, Fierce Pharma’s Fraiser Kansteiner interviews Delara Motlagh, head of cell therapy at Catalent; Becky Butler Cap, senior vice president of biotherapies at Vitalant; and Kevin Kyle, CEO of Germfree. The conversation covers cell collection, the critical first step in advanced therapy manufacturing.

Summary: In this ebook, access expert insight into analytical approaches for traditional biologics, including advanced therapies.

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

Watch this webinar to explore how Catalent's robust cell-based potency assays can enhance your research and provide critical data on drug product potency.

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.

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.