Tuesday, August 8, 2017 Daily Archives

From the Editor: BioProcess International Theater

This special insert summarizes our well-attended BioProcess Theater at the BIO International Convention in San Diego this past June. Focusing on emerging therapies and technologies enabled us to touch upon interconnected topics of interest to both BPI readers and the BIO exhibit-hall attendees. Speakers highlighted approaches ranging from analytical development to evolving business and commercial models. On behalf of our publisher, Brian Caine (who creates these programs every year) and our marketing and editorial teams, I thank the speakers and…

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…