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Apr 1, 2010 (Vol. 30, No. 7)

Cell Culture Moving Past Previous Technical Limits

Researchers Employ Insect and Duck Cells, Novel Media, and Next-Generation Automation Technologies

  • Regulatory Hurdles

    Manufacturers report that the greatest challenges to the widespread adaptation of cell-culture production techniques in the vaccine industry are regulatory.

    Vivalis undertook a stringent and extensive characterization of the sanitary status of the EB66 cell line and thoroughly documented its history and the procedures necessary for its establishment, according to Dr. Mehtali. That information was included in the biological master file that was submitted to the FDA in 2008. The company anticipates receiving an IND for a human vaccine sometime this year.

    Much to its chagrin, Protein Sciences’ process is basically regulated as a vaccine and as a recombinant protein—a combination that is not yet commonplace for regulatory bodies. Consequently, both sides have a learning curve. “We’re in the final stages of licensing with the FDA,” Dr. McPherson notes.

  • Media

    Ferruccio Messi, Ph.D., founder of Cell Culture Technologies, has developed minimal culture environments that streamline the purification process for cell-culture based products. “They are protein- and peptide-free and consist of a mixture of water and molecules only,” he says, which simplifies purification.

    A complex culture medium is, by its very nature, an undefined nutrient mixture, Dr. Messi stresses. “You can’t control your culture process if you don’t know what’s around the cell. Cells continuously interact with their environment, and if you don’t know what’s in that environment, there’s no way to accurately predict how cell metabolism will be affected.

    “With our technology, we eliminate that problem.” Cell Culture Technologies’ minimal culture media are made exclusively of tissue culture, water and chemically defined small molecules. Consequently, users can develop a methodology that governs cell behavior, based upon understanding and maintaining the nutritional balance of the culture media.

    “There’s also an advantage in upstream development by knowing what chemicals surround the cell.” That results in better control, which produces a more consistent outcome, lower costs, and speeds purification. “Product can be harvested in almost a purified form.”

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