2016

Case Study: Overcoming the Design Challenges of Expanded Bed Adsorption Columns

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Eduard Noguera (managing director, Grifols) BPI Theater @ INTERPHEX, April 27, 2016, 11:20–11:40 am Hematologist Dr. Jose Antonio Grifols pioneered blood banking and transfusions and founded the Grifols company in Spain, 1940. Present-day Grifols specializes in plasma and protein therapies. Grifols Engineering focuses on design and equipment for process engineering. The speaker has worked for this company for about 15 years in process engineering, including fill-finish processes. He described the company’s invention — the Grifols filling method — which prevents…

August 11, 2016

Utilizing Environmental Monitoring to Ensure Facility State of Control

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James D. Vogel (founder and director, The BioProcess Institute) BPI Theater @ INTERPHEX, April 27, 2016, 11:40 am–12:00 pm James Vogel introduced the concept of trending and how to use it to improve a manufacturing facility’s performance. Trending is defined as collecting data and then examining that information for trends — for example, modeling data to forecast the weather. Sometime a simple graph tells you as much as more advanced statistics can. The key is to pay attention to present…

August 11, 2016

Getting the Most in Training for New Technologies

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A BPI Theater Roundtable at Interphex 2016 On Wednesday, 27 April 2016, BioProcess International and the Biomanufacturing Training and Education Center (BTEC) at North Carolina State University (Raleigh, NC) presented an afternoon training symposium in the BPI Theater at Interphex 2016. Brian Caine, BPI’s cofounder and publisher, offered some opening remarks: “The purpose of these theaters and BioProcess International magazine is to talk about trends and their combined impact on bioprocessing. With the tremendous amount of new technology and products,…

August 11, 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