Abstract: Catalent’s Rapid Antibody Gene‑to‑Drug Substance program provides an accelerated, end‑to‑end pathway to move traditional monoclonal antibody programs from gene construct to GMP drug substance in as little as eight months.

Abstract: Presented at BioProcess International US West (BPI West) 2026, this session addresses the persistent challenges associated with difficult-to-express biologics, including bispecific antibodies and complex recombinant proteins, which often result in low titers, extended timelines, and scalability risks.

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

Catalent has expanded its industry‑leading GPEx® Lightning platform to include HEK cell line development, creating a new standard for speed, expression control, and product quality in human-cell–based manufacturing.

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

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.