This Month’s Issue

The January Upstream Processing issue features a cover photo of overconfluent five-day culture of CHO-K1 cells growing on a culture dish — courtesy of author Marcos Simón (www.boltonbioreactor.com). Read it Now.

Special Report

CMC Strategy Forums, Part 1: QbD and Risk Management

Read it Now.

Manufacturing

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The Single-Use Watering Hole: Where Innovation Needs Harmonization, Collaboration, and Standardization

Within the past few years, the single-use technology (SUT) arena of the biopharmaceutical industry has exploded in growth. Leading organizations have predictably and understandably stampeded to the “watering hole” of single-use to drink up the advantages that disposable components offer over traditional multiuse parts and technologies. The initial value and risk-reduction results are being realized — but not without the emergence of other trade-offs. End users continue to call for standardization in emerging areas of the industry while also recognizing…

H1N1 influenza virus (WWW.VISUALSCIENCE.RU.COM)

Downstream Processing

Fundamental Strategies for Viral Clearance – Part 1: Exploring the Regulatory Implications

Over the past several decades, biologics such as monoclonal antibodies (MAbs) and recombinant proteins have provided therapeutic benefits and efficacy for the treatment of human disease. Completion of the human genome project (launched in 1990) produced a draft of the genome in 2001. A full sequence was published on the 50th anniversary (2003) of the initial publication of Watson and Crick’s papers on the double-helical structure of DNA (1). That large volume of genetic information has been translated into usable…

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Manufacturing

Perfusion’s Role in Maintenance of High-Density T-Cell Cultures

T-cell therapy is a rapidly growing field of personalized medicine, attracting the interest of venture capitalists and pharmaceutical companies alike. Such therapies exploit T cells’ innate abilities to protect against pathogens as well as to seek and destroy cancerous cells. Although many different forms of T-cell therapies are currently in clinical trials, they all follow a common protocol: T cells are isolated from a patient, modified and expanded in a laboratory setting, and then infused back into the same patient…