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.

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

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

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: 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 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.

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).

Summary: Catalent offers a comprehensive suite of bioassay development services for traditional biologics and advanced therapies, such as antibody-drug conjugates (ADCs), cell and gene therapies, and mRNA vaccines.

Catalent has developed a relative potency bioassay using quantitative polymerase chain reaction (qPCR) to assess relative transcription activity in cells treated with ligands or transgenic vectors. The assay platform can be used to qualify a repeatable, accurate, linear, and specific bioassay for assessing relative potency for CGTs, mRNA- and other nucleic acid-based therapies.

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). Our comprehensive, standalone analytical services for ADCs are conducted by our in-house experts and tailored to meet your needs, regardless of scope or phase.