BPI Theater @ BIO 2016

Emerging Biotherapies and Their Manufacturing Challenges

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A BPI Theater Roundtable at the 2016 BIO Convention On Tuesday, 7 June 2016, Patricia Seymour (senior consultant in process development at Bio Process Technology Consultants) chaired a lunchtime roundtable titled, “Emerging Bio-Therapies and Their Manufacturing Challenges.†She brought together a panel of three industry experts: Mark Angelino (senior vice president of pharmaceutical sciences at BlueBird Biotechnology) Andreas Weiler (global business unit head of emerging technologies at Lonza) Chris Chen (chief executive officer of WuXi Biologics). Mark Angelino (BlueBird Biotechnology)…

August 11, 2016

Industrialization and Commercialization of Gene and Cell Therapies

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A BPI Theater Roundtable at the 2016 BIO Convention On Tuesday, 7 June 2016, Mike Ward (global director of content at Informa) chaired an afternoon roundtable titled, “Challenges Associated with the Industrialization and Commercialization of Gene and Cell Therapies.†He brought together a panel of four experts: Morrie Ruffin (managing director, Alliance for Regenerative Medicine, ARM) Michael Werner (ARM’s executive director) Sarah Haecker Meeks (chief scientific officer, Adjuvant Partners; director of technology sections, ARM) Tom Novak (vice president of strategic…

August 11, 2016

How to Manufacture and Deliver the Drugs of Tomorrow

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Andreas Weiler (global business unit head for emerging technologies, Lonza), BPI Theater @ BIO, June 7, 2016, 11:00–11:20 am How do we know what the future will look like? If we look at preclinical products in the drug development pipeline, we know what is likely to come to the market over the next 5–10 years. We don’t know exactly which products will succeed, but we know the kinds of products that will be available. And a company such as Lonza…

August 11, 2016

Recent Advances for Rapid Development of High-Quality, Robust Mammalian Cell Culture

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Jozef Orpiszewski (senior director of program design, Fujifilm Diosynth Biotechnology), BPI Theater @ BIO, June 7, 2016, 11:20–11:40 am Fujifilm Diosynth Biotechnology is focused on accelerating bioprocesses from gene to finished products by shortening the time line, all while following quality by design (QbD) precepts and making processes as robust as possible. When this CMO started several years ago, the development time line was about 18–24 months. Using new tools, approaches, and innovations, the company has shortened that time to…

August 11, 2016

Continuous Disposable Multicolumn Chromatography: Emerging Technology to Enable More Efficient Clinical Downstream Processing

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John Moscariello (vice president of process development,CMC Biologics) BPI Theater @ BIO, June 7, 2016, 11:40 am – 12:00 pm Most recent innovations improving efficiency have been on the upstream side of biomanufacturing. On the downstream side, bottlenecks usually occur at the chromatography step. Chromatography is such a powerful tool in purification that bioprocessors simply cannot do without it. CMC Biologics is introducing multicolumn chromatography (MCC) to help solve this bottleneck. Batch chromatography involves a number of steps — equilibrate…

August 11, 2016

Optimizing Noninvasive Delivery of Biomolecules

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Julien Meissonnier (vice president of science and technology, Catalent), BPI Theater @ BIO, June 7, 2016, 2:00–2:20 pm The Catalent Applied Drug Delivery Institute (CADDI) is an organization that aims to improve comfort for patients and expand the use of advanced noninvasive delivery technologies. The institute was developed in 2012, when Catalent recognized a gap existing between academia and industry when it came to the science of noninvasive delivery. Through it, the company strives to foster the development of new…

August 11, 2016

Manufacturing for Chimeric Antigen Receptor (CAR) T-Cell and Gene Therapies

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Daniel Smith (chief scientific officer, Cobra Biologics) BPI Theater @ BIO, June 7, 2016, 1:40–2:00 pm Cobra Biologics has been active in gene therapies for 20 years. The company began by manufacturing plasmid DNA for use in gene therapy products. It rapidly moved into contract manufacturing and now has a broad offering of protein virus DNA, fill–finish services, wholesale vaccines, and biologics. Based in Europe, Cobra has a facility in the United Kingdom specializing in microbial plasmid production and viral…

August 11, 2016

Comprehensive Hands-On Training for Biopharmaceutical Manufacturing

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Nathaniel Hentz (assistant director of the analytical laboratory at BTEC) BPI Theater @ BIO, June 7, 2016, 2:20–2:40 pm The Biomanufacturing Training and Education Center (BTEC) is part of the College of Engineering at North Carolina State University. In addition to training students and employees in the bioprocess industry, it also provides training for investigators with the US Food and Drug Administration (FDA). BTEC can demonstrate an entire process through upstream production, downstream processing, and drug-product filling in its manufacturing…

August 11, 2016

Go Beyond: A Review of Tomorrow’s Biopharma Landscape from the Emerging Biotech Perspective

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Ruta Waghmare (director of worldwide emerging biotech market sales development in global pharma processing, Millipore Sigma), BPI Theater @ BIO, June 8, 2016 11:00–11:20 am Millipore Sigma recently surveyed emerging biotechnology companies, defining those as companies with US$500 million or less in annual revenues. Such companies reported that one of their greatest challenges is attracting investors despite a rise in venture financing. In North America, the amount of funds involved in each financing round has increased, but the number of…

August 11, 2016

Challenges in the Development of Biologic Drug Products

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Hanns-Christian Mahler (head of drug product services, Lonza), BPI Theater @ BIO, June 8, 2016 11:20–11:40 am A drug product transfers a biomolecule (drug substance) into a form that will be usable by patients. It contains the active ingredient with excipients and can include packaging or a device for administration. In many cases, patients must be able to administer drugs to themselves. “Think about how the drug will be administered before designing your formulation,†Mahler suggested. Keeping a biomolecule intact…

August 11, 2016