Drug developers face mounting challenges linked to rapid increases in demand for the complex modalities while also accounting for the need to drive process efficiencies at scale. Working with the right partner, that offers integrated services, can help ease the increasingly common problems with scale, access to high-demand raw material, viral vector production, and quality requirements.

Summary: Catalent Cell & Gene Therapy experts spoke with American Pharmaceutical Review to discuss how cell and gene therapies are changing the healthcare landscape and what needs to be done to bring these advanced therapies to patients.

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.

Summary: For Contract Development and Manufacturing Organizations (CDMOs), transitioning to Biopharma 4.0 is crucial – the data and expertise amassed by these manufacturers represent an integral asset for their customers working to innovate in an increasingly competitive and fast-paced market.

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.

Summary: Mike Riley, President, Catalent Biologics, will discuss the latest trends in ADC discovery and development, with a focus on how next generation pipelines are being shaped by payload and linker chemistry innovations, including those from Catalent’s award-winning SMARTag® ADC platform.

This article describes the benefits of transitioning from IV to SQ administration, considers the advantages of using PFSs, and explores challenges and solutions for transitioning from vials to PFS.

During this webinar, Catalent experts will discuss challenges associated with charged variants of biotherapeutic products, including monoclonal antibodies and fusion proteins.

Listen in as Mike and Darren share how new modalities and manufacturing technologies have altered the partnership landscape between developers and CDMOs.

Join us as our panel of experts discuss key manufacturing challenges for early and late-stage gene-enabled cell therapy programs, as well as how to overcome them through effective partnerships.