Abstract: Biopharma innovators face increasing pressure to advance monoclonal antibody programs to IND quickly without compromising product quality or downstream scalability.

AAV vectors offer clear benefits for gene therapy, and continued advances in technology have increased target specificity, improved potency, and intensified production efficiency.

AAV genomic integrity is based on defining the molecular DNA composition of recombinant AAV vector preparations, specifically, the presence of full-length, ITR-to-ITR genomes, and the relative amount of undesirable molecular sub-species encapsidated within AAV particles.

Abstract: CAR-T therapies have proven their curative potential, but cell therapy developers continue to face challenges related to manufacturing complexities, costs, scalability, regulatory compliance, and supply chain management.

Summary: This presentation introduces a systematic, data-driven approach for assessing the developability of biologic therapeutics, with a focus on pre-formulation development.

The cell line development technology platform revolutionizes the generation of complex biologics with unmatched speed, scalability, and flexibility.

In this webinar, Pedro Morales, Director and Scientific Advisor at Catalent, showcases how the Kansas City site delivers tailored analytical solutions to support biologics development from discovery through commercialization.

Plasmid DNA is a vital component in the production of viral and nonviral cell and gene therapies (CGT). Catalent's innovative UpTempo℠ Plasmid Platform Process has revolutionized plasmid DNA manufacturing by addressing key challenges and significantly reducing development time.

Catalent Biologics’ Limoges, France development center is our European center of excellence for early phase clinical biologics formulation development and drug product fill/finish.

Catalent’s mammalian cell line engineering and biomanufacturing capabilities, utilizing single-use systems, provide the flexibility and scalability needed to support our customers' growth.