BPI Theater

Panel Discussion: Emerging Biotherapies and Their Manufacturing Challenges

At noon on Tuesday, 20 June 2017, BioProcess International presented a panel discussion as part of the “Emerging Therapies” session of its BPI Theater at the Biotechnology Innovation Organization’s annual convention in San Diego. Moderated by Patricia Seymour (senior consultant at BioProcess Technology Consultants), this panel comprised Holger Wesche (vice president of research at Harpoon Therapeutics), Richard Snyder (chief scientific officer of Brammer Bio), Marc Better (vice president of product sciences at Kite Pharma), and Paulo Carvalho (associate director of…

New Tools to Improve Cell Viability, Purity, and Recovery

Presented by Sean Kevlahan (chief executive officer, Quad Technologies) 11:00–11:20 am Kevlahan described Quad Technologies as an early stage company founded in 2013 and headquartered in Woburn, MA. Its approach to cell and gene therapies is offering bioprocessing tools with a biomaterials focus. The company’s QuikGel platform is a hydrogel-based technology for making different sizes of hydrogel microbeads that will dissolve under gentle conditions. The beads can be magnetic or nonmagnetic for both research and bioprocessing applications. This technology provides Quad…

Advanced Therapies Capabilities at FDBT

Presented by Yan Zhi (program design technical lead, Fujifilm Diosynth Biotechnologies) 11:20–11:40 am Fujifilm Diosynth Biotechnologies Texas (FDBT) has two dedicated viral products facilities: The National Center for Therapeutic Manufacturing (NCTM) building was designed for process development and early phase clinical good manufacturing practice (GMP) production of advanced therapeutics including viral, microbial, and plasmid products. The newly built Flexible Biomanufacturing Facility (FBF) is designed for clinical and commercial GMP production of viral products. View the full video here – Login Required…

Covering a Spectrum of New Product Development Technologies: From Cells to Cell Therapy

Presented by Stewart McNaull (senior vice president of business development, KBI Biopharma) 11:40 am–12:00 pm Founded in 2004, KBI Biopharma operates a core facility in Durham, NC. In 2013, the company needed more space and set up laboratories in Research Triangle Park, NC. Using mammalian cell lines, it has developed both monoclonal antibody (MAb) and non-MAb platforms. It acquired a former Merck site in Boulder, CO, in 2014 and retained staff experts in fermentation expression, refolding, and mass spectrometry. With manufacturing…

Navigating the Road to Commercialization Together

Presented by Cyril Peter (senior proposal manager, Lonza Pharma and Biotech) 1:00–1:20 pm A publicly traded company, Lonza focuses on drug sponsors that want to go to market with their own products. “To get there, you need to make a drug out of your molecule, manufacture it, go through clinical trials, and generate data for submission to regulatory authorities for market authorization.” That requires information about the molecule (critical quality attributes, CQAs) and on how you make it (critical process parameters,…

Increasing Cell Productivity and Quality in MAb Production By Focusing on a Novel Target

Presented by Adam Elhofy (chief science officer, Bio-Ess Laboratories) 2:00–2:20 pm “What we call biomanufacturing,” said Elhofy, “is all about cells. When cells get cranked up, they start to have deficiencies — and those deficiencies lead to different protein quality, to aggregates, and to a loss of consistency in protein quality. So how do you improve productivity and protein quality?” Bio-Ess Laboratories (formerly Essential Pharmaceuticals) has a technology to address the role that lipids play in cell productivity. View the full…

Advancing the MAb Therapies of Tomorrow

Thomas Page (vice president, engineering and asset development, Fujifilm Diosynth Biotechnologies USA) 1:00–1:20 pm Page introduced Fujifilm Diosynth’s Saturn monoclonal antibody (MAb) platform, which is based on the Apollo cell line. A senior team working from three facilities designed this new platform by challenging everything from previous designs, keeping the best aspects, and throwing out what did not work well — while innovating where necessary. All functional units were represented and empowered to make decisions. The team used risk-based tools…

Panel Discussion: How CMO Business Models Have Adapted to Meet the Challenges and Opportunities of Protein-Based and Emerging Therapy Markets

On Tuesday, 20 June 2017, BioProcess International presented a panel discussion from 1:20 to 2:00 pm as part of the “Emerging Therapies” session of its BPI Theater at the BIO annual convention in San Diego. Moderated by Gil Roth (president of the Pharma and Biopharma Outsourcing Association), the panel comprised John Foy (vice president of business management for biologics at Patheon), Michael A. Riley (vice president and general manager of Catalent Biologics), Victor Vinci (vice president and chief scientific officer…

Panel Discussion: Cell, Gene, and Tissue Therapies — Applying Key Lessons from the Evolution and Commercialization of Protein-Based Therapies

On Tuesday, 20 June 2017, BioProcess International presented a panel discussion from 2:20 to 3:30 pm as part of the “Emerging Therapies” session of its BPI Theater at the BIO annual convention in San Diego. Moderated by David Brindley (University of Oxford and Harvard University), the panel comprised Morrie Ruffin (managing partner of the Alliance for Regenerative Medicine), David Backer (head of commercial development for gene editing and novel modalities at MilliporeSigma), Robert Preti (president and chief executive officer of…

Panel Discussion: Process and Business Considerations for Innovation — Supplier and End-User Perspectives

On Wednesday, 21 June 2017, BioProcess International presented a panel discussion from 11:00 am to 12:00 pm as part of the “Emerging Techniques and Technologies” session of its BPI Theater at the BIO annual convention in San Diego. Moderated by Tom Ransohoff (vice president of BioProcess Technology Consultants), the panel comprised Stewart McNaull (senior vice president of business development at KBI Biopharma), Bernard Huyghe (senior director at Pfizer), John Bonham-Carter (director at Repligen, not pictured), and Todd J. Menkhaus (cofounder of…