Pall Life Sciences has long been known for its expertise in processing and filtration equipment for the biopharmaceutical industry. In recent years, the company has broadened its offerings in upstream manufacturing by expanding its core capabilities in the single-use, bioreactor, and microcarrier arenas, with unique and innovative technologies for cultivation of cells to be used as therapies. Read the full text of this article in the PDF (Login required).
On 12 March 2015, BPI publisher Brian Caine and editor in chief Anne Montgomery spoke with Harvey Brandwein, Pall’s vice president of business development, at the company’s Port Washington, NY, facility. Pall’s director of marketing for cell therapies, Alain Fairbank, also provided her thoughts on the evolution of tools and technologies for this market sector. Knowing that this interview would become one of the concluding chapters in Pall’s special issue with BPI, we reviewed a number of topics covered earlier,…
Accelerator Development Services Applications: Bioprocess consulting, process development, and qualification Features: Pall Life Sciences supports customers with an experienced team of scientists and engineers — from on-site guidance to larger projects in its own process development laboratories. PadReactor® Single-Use Bioreactors Applications: Flexible for suspension- adapted and adherent cell cultures Features: The PadReactor family of single-use bioreactors is designed for cell culture applications. These systems are linearly scalable (5–1,000 L) and suited from laboratory-scale process development to large-scale GMP manufacturing. They…
Welcome to our first full issue of summaries from our 2015 BioProcess Theater programs. This is a bit of a different concept and format from our regular issues and supplements, so a few words of explanation are necessary. At the Interphex conference (21–22 April 2015) and the Biotechnology Industry Organization’s annual convention (16–18 June 2015), BPI again organized and conducted presentation programs within the exhibit halls. We have been holding the BPI Theater @ BIO for eight years now, and…
Matt Feldman (senior manager of strategic communications, Aeras) 10:00–10:25 am Vaccines, Global Health, and the Future of Fighting Tuberculosis Aeras is a nonprofit biotechnology company located in Rockville, MD, with other locations in Beijing, China, and in Cape Town, South Africa. Its mission is to advance tuberculosis (TB) vaccines worldwide. The fully integrated biotech company has in-house capabilities in finance, portfolio management, and manufacturing, taking products from preclinical through phase 2b clinical trials. Aeras is governed by a board of…
Bill Hartzel (director of strategic execution for advanced delivery technologies, Catalent Pharma) 1:30–1:55 pm Reducing the Risk Associated with the Filling of Biologics with Advanced Aseptic Processing Hartzel discussed leveraging “blow–fill–seal†(BFS) aseptic processing technology to reduce risks associated with biologics fill and finish. A number of drug recalls have been associated with microbial and particulate contamination of glass vials, problems that could be solved using BFS. Automation eliminates human intervention at this critical stage, driving out associated risks. Hartzel…
Tony Hitchcock (technical director, Cobra Biologics) 1:30–1:55 pm The Expanding DNA and Gene Therapy Market The gene therapy market has fluctuated dramatically over the past 20 years. But Hitchcock noted that over the past three years there has been a huge emergence of successful clinical outputs of gene therapy, with a large number of IPOs and significant funding. Even more interesting is the number of large pharmaceutical companies bringing gene therapy into their portfolios. Hitchcock pointed out that it is…
On Tuesday, 21 April 2015, Eric S. Langer (managing partner at BioPlan Associates) chaired a midday roundtable titled, “Deciding on Single-Use vs. Stainless Steel Bioprocessing Strategy: What Do CMOs Know That Biopharmas Don’t?†Langer brought together these industry experts to discuss choosing between stainless steel and single-use technologies (SUTs) for different applications: William Hartzel (director of strategic execution at Catalent Pharma Solutions) Steven Perry (vice president of technical operations at Cook Pharmica) Joanna Pezzini (bioprocess engineer at MedImmune) Daniel Vellom…
Andrew Lidums (NA business development manager, Parker domnick hunter) 2:30–2:55 pm Implementing a Risk-Management–Based Approach to the Prevention of Mycoplasma Contaminations Lidums began with a recent report from Genentech, where a 150-µm long Leptospira organism from a drainage ditch outside the facility managed to penetrate 0.1-µm filters. The company solved this problem by lowering the temperature of the filtration operation, which made the bacteria more rigid and kept them from getting through. Clearly, however, contaminations happen even at large facilities.…
On Wednesday, 22 April 2015, Susan Dexter (principal consultant at Latham BioPharm Group) chaired a midday roundtable titled, “Fill and Finish Manufacturing Strategies: Better or Just New?†She brought together three industry experts to provide mixed perspectives: Joseph Figlio (senior project officer for the manufacturing facilities and engineering division of the Biomedical Advanced Research and Development Authority, BARDA, in the US Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response) Victor Lee (vice president…