In this webinar, experts will discuss the evolution of protocols associated with induced pluripotent stem cell generation and differentiation.

Summary: One significant challenge in the manufacturing of cell and gene therapies is the production of high quality plasmid DNA (pDNA). pDNA is a critical raw material for advanced therapeutics including mRNA and viral vector-based cell and gene therapies and vaccines.

In this webinar, experts will discuss the evolution of protocols associated with induced pluripotent stem cell (iPSC) generation and differentiation.

In this webinar, experts will discuss how to improve the formulation development of high-concentration mAbs for subcutaneous delivery to reduce viscosity, and potentially reduce costs and timelines, and how to overcome current challenges met in formulating mRNA lipid nanoparticles (mRNA-LNP).

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.