Featured Content

In the latest issue of BioProcess International we feature 40 application notes from the leading suppliers and service providers in the biopharmaceutical manufacturing industry.

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BioProcess International Theater Supplement

Our second annual BPI Theaters supplement once again brings you summaries from presentations at our BioProcess Theaters during Interphex and the BIO Convention. These presentations highlight the critical transitions underway in the bioprocessing industry.

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Sanofi-ProductionPlant-Sisteron

Deciding Between Single-Use and Stainless Steel Strategies

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…

2,000-L stainless steel bioreactor

Upstream Processing

Bioreactor Manufacturing Platforms for Cell Therapies

As an increasing number of cell therapies move into late-phase trials, developers are considering innovative solutions to address scale-up and commercialization challenges. Many of their questions focus on the technologies and engineering strategies that will be needed to optimize their processes, especially bioreactors. At the January 2016 Phacilitate Cell and Gene Therapy World conference, Siddharth Gupta, a scientist at Lonza (Walkersville, MD), talked about the effects of upstream process decisions on product quality in his presentation “Bioreactor Manufacturing Platforms: So…

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Manufacturing

Future Manufacturing Strategies for Biosimilars

Biosimilars are a relatively new subset of biopharmaceuticals, with the biotechnology industry finally maturing such that off-patent generic-type products increasingly will be entering major markets (1–3). So far, more than 20 biosimilars for a limited number of reference products have been approved in major markets, primarily the European Union. Only two products have been formally approved as biosimilars in the United States. For this rapidly growing industry sector, little consensus or authoritative information is available yet regarding how and where…