BPI Theater

Product Development Through Commercial Production: Guiding Your Biologic from Start to Finish

Eunyoung Yang, team leader and chief development officer of the business development team, Samsung BioLogics Samsung is maximizing customer satisfaction by providing customized, cost-effective, and comprehensive development and manufacturing services. It is the number-four company in the world worth, US$92.3 billion, with 672 offices in 91 countries and employing 512,000 people. Samsung provides electronics (its most well-known business), engineering and construction for heavy industries, financial services, and healthcare support including biologics manufacturing, a medical center, and electronic medical devices. Samsung…

The Perks and Pitfalls of a Single-Use Biopharmaceutical Facility

Sun Ra Bullins, director of manufacturing, Avid Bioservices Avid Bioservices is a dedicated commercial contract development and manufacturing organization (CDMO) with over 13 years of commercial manufacturing experience. It received six CMO leadership awards in 2018. Avid has a new state-of-the-art facility (2016) in Myford, CA, which has been designed for fully disposable manufacturing with up to 2,000-L capacity; and a legacy commercial facility with stainless steel bioreactors up to 1,000 L in Franklin, CA. In designing the Myford facility,…

CMO Fusion: Where Stainless Steel Meets Disposable Technology

Molly McGlaughlin, director of strategy and business development, BioVectra  Jim Stout, director of process science, BioVectra   McGlaughlin introduced BioVectra. The company has been in business for 45 years and is based in Canada. Its a well-established contract development and manufacturing organization (CDMO) and fine-chemical manufacturer, and is a subsidiary of Mallinckrodt Pharmaceuticals. BioVectra started out as diagnostic reagent company and now has a complementary set of niche capabilities. From 10 years of fermentation experience, it was a logical progression to…

BioProcess Insider Interviews at the BPI Theater @ BIO 2018 – Mass Bio and Bioasis

At the BPI Theater @ BIO, editor Dan Stanton conducted a series of interviews live on stage to report on the latest movements in the biomanufacturing industry to start each busy day of dealmaking in Boston. Below are the videos from conversations with David Lucchino, chairman, Mass Bio; and Mark Day, president and chief executive officer, Bioasis. Massachusetts: Secrets to Success Lucchino explains that when you have a set of companies in an area, it lays the groundwork for growth…

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. The NCTM boasts 14 first- and second-generation mobile…

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. The company has…