This Month’s Issue

Illustrating this month’s production theme, a fermentation suite at the Biomar Microbial Technologies CMO site in Lyon, France (www.biomar.com).

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April Supplement


Cell Therapies: Accelerating Affordable Growth

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Analytical

PLBL2 models from PSI, the online protein model portal WWW.PROTEINMODELPORTAL.ORG

Hamster Phospholipase B-Like 2 (PLBL2): A Host-Cell Protein Impurity in Therapeutic Monoclonal Antibodies Derived from Chinese Hamster Ovary Cells

All recombinant protein biotherapeutics must be tested for the presence of residual host-cell protein (HCP) impurities (1–3). The most common analytical method for doing so is a polyclonal sandwich immunoassay. Polyclonal anti-HCP antibodies are selected to recognize the broadest population of HCPs possible. The immunogen and analytical standard are produced from a blank-run fermentation that mimics the production run but lacks the specific biotherapeutic protein. Because of the large number of impurities present in harvested cell-culture fluid (HCCF) that might…

Technology transfer moves a process into a different environment and as a result, the
product should be properly defined before the transfer is initiated. Before technology transfer, raw
biological material collection (e.g., bone marrow, apheresis) and manufacture may be colocated,
typically at a clinical site (a). Following technology transfer, clinical and manufacturing sites are no
longer in close proximity (b).

Manufacturing

Are You Ready for a Tech Transfer? Part 1: Challenges and Critical Factors for Success in Cell Therapy Development

Cell therapies offer enormous promise for treatment of a range of conditions by replacing damaged tissue or leveraging the body’s own resources to heal itself. Not surprisingly, the cell therapy industry is growing rapidly and is poised to have a major impact on healthcare and disease treatment. The Alliance for Regenerative Medicine (ARM) has reported on the robust state of the industry, noting that revenue from cell-derived products grew from US$460 million in 2010 to $1.3 billion in 2013 (1).…

FUJIFILM DIOSYNTH BIOTECHNOLOGIES (WWW.FUJIFILMDIOSYNTH.COM)

Business

QBD Manufacturing Strategies: The CMC Strategy Forum Series, Part 2

The CMC Strategy Forums provide a venue for biopharmaceutical product discussion. They focus on relevant chemistry, manufacturing, and controls (CMC) issues throughout the life cycle of a therapeutic and thereby foster collaborative technical and regulatory interaction. Forum chairs share information with regulatory agencies to help them merge good scientific and regulatory practices. Outcomes of the forum meetings are published in BioProcess International and on the CASSS website. This process is meant to help ensure that biopharmaceutical products manufactured with advancing…