Catalent’s Anagni facility is a world-class, late-stage and commercial product launch site offering sterile and biologics manufacturing & secondary packaging with extensive expertise in aseptic liquid vial filling.

Summary: iPSCs are a critical starting material for advanced cell therapies. Learn more about Catalent’s GMP iPSC capabilities including reprogramming, differentiation, and cell banking, and how they can advance cell therapies to clinic.

Summary: Leveraging Catalent’s proven GPEx expression platform in a glutamine synthase (GS) knock-out Chinese hamster ovary (CHO) cell line system, GPEx Lightning combines innovative technologies, including a novel gene insertion technology, to further shorten drug substance development by up to three months compared to previous timelines.

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. Catalent iPSC expert Boris Greber discusses 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.