A BPI Theater Roundtable at Interphex 2016 On Tuesday, 26 April 2016, Eric S. Langer (managing partner of BioPlan Associates) chaired a morning roundtable titled “Deciding on Single-Use vs. Stainless Steel Strategy: What the CMOs Know That Biopharma Needs” as a follow-up to a similar discussion held last year. Langer brought together a panel of four contract manufacturing organization (CMO) industry experts: Daniel Vellom (senior director of global technology innovation at Sanofi Pasteur) Sue Behrens (senior director of process technology…

A BPI Theater Roundtable at Interphex 2016 On Tuesday, 26 April 2016, James D. Vogel (founder and director of The BioProcess Institute at the University of Rhode Island) chaired a midday roundtable titled, “Single-Use Harmonization Town Hall: Coordination of SUS Standards and Best Practice Efforts.” Two industry experts joined him in a panel discussion: Mike Johnson (business development engineering manager for Entegris) Jeff Carter (strategic projects leader at GE Healthcare). All three are members of different groups interested in developing…

Mark Arjona (product line manager, Distek) 1:00–1:20 pm The bioprocessing industry has embraced single-use technologies recognizing their benefits of safety, cost, and throughput. Based in New Jersey, Distek is a leading manufacturer of single-use equipment. The BIOne is a single-use bioreactor system consisting of a patent-pending, disposable headplate and liner that fit together into a bench-scale glass vessel. The liner molds to the contours of culture vessels (3 L or 7 L), keeping their geometry, aspect ratio, and volume all…

Jim Furey (general manager, PendoTECH) BPI Theater @ INTERPHEX, April 26, 2016 11:30 am–12:00 pm Located in Princeton, NJ, PendoTECH was founded in 2005. The company develops equipment for single-use systems and promotes the concept of automation. It produces sensors, monitors, transmitters, and standard process control systems with the ability to collect and store data, as well as customized solutions. PendoTECH staff have many decades of experience in product development, project management, embedded software development, graphical-interface programs, and mechanical engineering.…

Peter Levison (senior director, Pall Life Sciences ) BPI Theater @ INTERPHEX April 26, 2016, 1:40–2:00 pm Pall’s advancements in integrated continuous bioprocessing include new product launches. The company has built a continuous laboratory at its facility in Westborough, MA. It is 6 m × 6 m and can produce >2 g of pure monoclonal antibody (MAb) per hour. One continuous process flows through one step to the next, from cell culture to formulation. Continuous manufacturing is being used successfully…

Bill Hartzel (director of strategic execution, Catalent Pharma Solutions) BPI Theater at INTERPHEX, April 27, 2016 11:00–11:20 am How do biopharmaceutical companies leverage technology to provide unique primary container– closures to the market space? Catalent uses an advanced aseptic process of blow–fill–seal (BFS) technology. Adding automation makes for an efficient process that can reduce or eliminate human intervention needed in critical drug-product filling applications. Catalent’s system uses one automated machine in which a container is quickly formed, filled, and sealed…

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…

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…