AAV gene therapy programs face long development cycles, raw material variability, and complex scale-up demands.

Summary: Cell and gene therapies continue to expand across oncology, cardiovascular, and CNS diseases, yet production remains limited by talent shortages, complex supply chains, and slow development cycles.

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: As the biopharma landscape grows more complex, Catalent works to ease the challenges of biologics development for its partners.

Summary: Biotherapeutics are becoming increasingly sophisticated, often requiring the coordinated expression of multiple genes, processing enzymes, and cofactors.

Summary: This poster presents a customized mass spectrometry approach for sub-ppm quantitation of high-risk host cell proteins (HCPs) considered critical quality attributes.

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

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: Catalent’s Bio Early Phase Success Package delivers an integrated analytical strategy designed to de-risk biologics development from discovery through IND.

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