Presented by: Gregory Bleck, PhD, vice president, Catalent Biologics Speed and efficiency remain major drivers for developers bringing their protein-based biologics to first-in-human studies. The right cell-line development approach can help streamline a path to clinic for both standard monoclonal antibodies and more complex modalities such as bispecifics. Bleck shared recent data on how the GPEx suite of technologies provides for high titers, short timelines, and flexibility in cell-line development for mammalian-expressed proteins. He began by explaining that protein therapeutics can…

Presented by: Anil Sebastian, group leader, cell culture development; and Joachim Klein, head of microbial strain development and cell banking, Lonza Pharma & Biotech Although monoclonal antibodies (MAbs) remain the most popular modality in the biopharmaceutical industry, new molecular formats (NMFs) such as multitoxin antibody–drug conjugates and multichain antibodies are gaining ground quickly. Such molecules are imposing new demands on gene-expression technologies. Sebastian and Klein described how their company’s solutions support upstream development for therapies based on NMFs. Sebastian highlighted…

Presented by: Maria Patrício, lead scientist for viral design and discovery, Oxgene, a WuXi Advanced Therapies company Building upon colleague Jason King’s BPI Theater presentation on transient transfection platforms for viral-vector production, Patrício focused on scalable manufacturing solutions for adenoassociated virus (AAV), the vector used most often to deliver gene therapies. AAV naturally requires a helper virus to replicate. Plasmid transfection enables helper-free manufacture, but that process is difficult to manage at commercial scales. A more scalable approach is to…

Presented by: Evan Zynda, staff scientist, Thermo Fisher Scientific Cell therapy companies increasingly are pursuing allogeneic therapies to negotiate manufacturing challenges associated with autologous approaches. Products based on high-quality cells from healthy donors could improve therapeutic efficacy. Allogeneic approaches also could facilitate large-scale therapy production, which in turn could reduce time-to-treatment and increase therapy affordability and accessibility. Zynda showed how increased understanding of T-cell biology could help improve allogeneic workflows. Zynda emphasized the utility of studying signaling pathways associated with…

Presented by: Jason King, business development manager, Oxgene, a WuXi Advanced Therapies company Since joining the WuXi Advanced Therapies division of WuXi AppTec in March 2021, Oxgene has focused on helping gene therapy developers to optimize their viralvector production systems as they transition from preclinical and early clinical projects to good manufacturing practice (GMP)-grade manufacturing. King observed that early stages of gene therapy development nearly always involve systems for transient transfection rather than scalable platforms. Inducible producer cell lines, viral…