Breakthrough in Gene Expression Technology for Monoclonal Antibodies

Scientists at Cell Genesys, Inc., have developed a proprietary gene expression technology that enables the production of full-length monoclonal antibodies at commercially relevant levels from a single production cell line. This innovative technology, which uses adeno-associated viral (AAV) or other viral-based genetic engineering, can significantly shorten the time required to develop cell lines for commercial production from months to weeks. The technology has broad application in commercial-scale production of monoclonal antibodies and other complex therapeutic proteins, as well as in the long-term administration of therapeutic antibodies to patients.

Key Takeaways:

• The new gene expression technology enables the production of full-length monoclonal antibodies at commercially relevant levels from a single production cell line.
• This technology can significantly shorten the time required to develop cell lines for commercial production from months to weeks.
• The production levels achieved with this technology may be more than double those achieved with conventional technologies.
• This technology has broad application in commercial-scale production of monoclonal antibodies and other complex therapeutic proteins.
• It may also have application in the long-term delivery of therapeutic antibodies, which are currently administered by repeated injection into patients.
• Chronic diseases such as cancer and arthritis may require long-term and repetitive antibody treatment regimens, which this technology may help address.
• The technology has been demonstrated to result in continuous expression of biologically active monoclonal antibodies at high concentrations in vivo for over 4 months, and such treatment has significant anti-tumor activity in preclinical tumor models.
• The technology can potentially provide the same advantages to the production of therapeutic protein products, including those comprised of multiple subunits or polypeptide chains, such as Factor VIII and chimeric proteins such as TNF-alpha IgG (infliximab).
• The technology may have the potential to save up to a year in overall development time, making it more efficient than current antibody manufacturing technologies.
• This technology may lead to the development of cost-effective delivery methods for therapeutic antibodies, reducing the need for repeated injections into patients.

Statistics:

• The production levels achieved with the technology may be more than double those achieved with conventional technologies (working in partnership with Research and Development team).
• The technology can potentially save up to a year in overall development time (making it more efficient than current antibody manufacturing technologies).
• The technology has been demonstrated to result in continuous expression of biologically active monoclonal antibodies at high concentrations in vivo for over 4 months.
• Therapeutic antibodies are currently administered by repeated injection into patients, which may be a less effective and more costly approach.

Sources:

• "Research and Development" via Cell Genesys, Inc.,
• "Peter K. Working, PhD, senior vice president of research and development" via Cell Genesys, Inc.,
• "Nature Biotechnology" via online issue, April 17.