Demand continues to grow for clinical- and good manufacturing practice (GMP)-grade plasmid DNA (pDNA) amid the proliferation of therapies based on mRNA and viral vectors. At a newly acquired manufacturing facility in San Diego, CA, Wacker Chemie is expanding its capabilities with a scalable platform for pDNA production. In October 2021, Mack Kuo (associate director of bioprocess development at Wacker Biotech US) showcased the site’s capabilities and described how it can provide comprehensive, customizable services for plasmid production. Kuo’s Presentation…

The novel coronavirus pandemic has exposed vulnerabilities in biopharmaceutical industry approaches to supply-chain management. Drug developers and manufacturers have tended to presume suppliers’ access to raw materials for bioprocess components. However, global crises disrupt reliable access. Ari Ojinaka (production manager at Astrea Bioseparations) joined BPI in October 2021 to explore strategies for navigating supply-chain uncertainty. He described how his company seeks to optimize manufacturing capacity, enhance communication with its suppliers and customers, and support a quality-driven company culture. Ojinaka’s Presentation…

During process development (PD), single-use (SU) bioreactors can streamline cell-culture workflows and reduce risks for contamination and operator errors. But transferring cultures from laboratory- to benchtop- and pilot-scale vessels requires consideration of fundamental bioreactor principles. In October 2021, Ann D’Ambruoso (manager of product applications and marketing) and Cristina Bernal Martinez (applications support engineer, both at Getinge) reviewed factors for scale-up success and presented a case study involving transfer of cell cultures to Applikon AppliFlex SU stirred-tank (ST) reactors. The Presentations…

In November 2021, Rathangadhara Nammalwar (manager of protein-based therapeutics at Sartorius) delivered a presentation describing the hallmarks of a robust cell line development (CLD) platform. Focusing on the importance of expression constructs, he then explained how collaboration with external partners has enabled Sartorius to optimize its Cellca CLD platform for mammalian-cell production of therapeutic proteins. Nammalwar’s Presentation Nammalwar identified key criteria for selecting a CLD platform, noting first that it should leverage a highly productive cell line that yields high-quality…

Despite safety-related setbacks in the early 2000s, adenovirus (Ad) again is gaining traction as a vector for advanced therapies and vaccines. Thus, Ad production is accelerating. In November 2021, Hana Jug (project manager in process development for viral vectors and vaccines at BIA Separations, a Sartorius company) described how her company’s updated platform process for Ad vectors could enhance their purification, maximizing recovery of critical vaccine components. Jug also highlighted BIA’s abilities to supply chromatographic columns consistently and to support…

During a December 2021 presentation, Matthew Lotti (senior research associate in analytical development at Ultragenyx) highlighted difficulties with determining adenoassociated virus (AAV) capsid titers during gene therapy production. With support from Gyros Protein Technologies, Lotti spoke about his team’s development of a method for measuring AAV titers using a Gyrolab xPand immunoassay system. Lotti’s Presentation Simple analytical methods such as UV spectrophotometry measure capsid titers most effectively after virions have undergone purification. To test samples from earlier process stages, Ultragenyx…