Found 258 results in Expert Content

Human induced pluripotent stem cells (iPSCs) enable availability of next-generation cell therapies for broader patient population at a faster turnaround time for a variety of disease areas. Two Catalent Cell & Gene Therapy experts discuss the use of iPSCs as starting materials for cellular therapies, including the concept behind a universal platform for iPSC-based therapies.

Catalent Biologics' Limoges, France site is our European center of excellence for early phase clinical biologics formulation development and drug product fill/finish. The site offers an integrated facility with a small-scale filling line, in-house analytical capabilities, quality control labs, cold storage, and regulatory support.

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.