LA JOLLA, Calif., Feb. 20, 2014 /PRNewswire/ — Cultivated mammalian cells, known as "mammalian fermentation," have become the dominant system for the production of recombinant proteins for clinical applications. To bring these products to market involves significant effort and continuous advances in process development. These efforts aim to increase the level of product understanding and identify those key quality attributes that help in reproducing product batches.
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Large-scale cell culture operations have improved tremendously in recent decades due to increased process understanding. Improvements in safety profiles have also been made with overlapping and redundant controls to prevent, detect, and remove potential adventitious agents. Process understanding is ultimately reduced to practice through a system of measurement, monitoring, modeling, and control for each unit operation in the bioprocess.
To address the current state of science and practice in this field, UC San Diego Extension will co-present a three-day course titled "Mammalian Fermentation Workshop," April 30 through May 2, at the UC San Diego campus.
Developed in partnership with UC San Diego's Center for Continuing Education in Biosciences (CCE-BIO), part of the Biological Sciences Division, the program features both UC San Diego faculty members and industry-based speakers.
"Today's sophisticated pharmaceutical drugs are not just chemicals, but also biological agents, such as proteins and antibodies," said Hugo Villar, director of science and technology at UC San Diego Extension. "Their production requires the use of cell culture and fermentation techniques that have become extremely important in the biotechnology and pharmaceutical industries, and it requires the optimization of a number of complex variables."
Villar added, "These new therapeutic agents require new means of production, completely unlike those used to produce traditional chemicals as drugs and they are subject to their own set of regulatory requirements."
Open to the public, the two-unit workshop is designed for professionals with a broad range of industry skills and experiences who wish to expand on their current knowledge and improve their ability to problem-solve. Having a rudimentary understanding of microbial or mammalian cell culture processes is advised.
The program's objectives include the following:
- Explore the history of mammalian cell biotechnology and challenges faced, specifically in the biopharmaceutical industry
- Gain an overview of the biotech manufacturing process, including regulatory, quality, and supply chain aspects
- Analyze key issues and tools used in industrial cell culture operations, including economies of scale and process flow diagrams
In addition, the three-day workshop will explore technology transfer, scale-up, and operational aspects of mammalian fermentation. The workshop will combine practical knowledge with case studies to provide participants with the ability to thoroughly analyze experimental cell culture results.
Among the featured instructors:
- Michael David, Ph.D., Professor of Molecular Biology, UC San Diego
- Michael Fino, M.Eng., Professor of Bioprocess Technology, MiraCosta College
- Michael Pohlscheidt, Ph.D., Director of Manufacturing Operations, Genentech; and
- Eric M. Fallon, Ph.D., Director of Technology, Genentech
The course also includes a site visit to Genentech, the San Diego-based biotech firm that has made significant advances in developing protein therapeutics to treat patients with serious or life-threatening medical conditions.
For more information and to register for this workshop, please visit UC San Diego Extension's website at http://extension.ucsd.edu/lifesciences or call (858) 534-9353.
About UC San Diego Extension:
As the continuing education and public programs arm of the university, UC San Diego Extension educates approximately 63,000 enrollees a year, which translates to about 33,000 students in nearly 4,300 courses. UC San Diego Extension is recognized nationally and internationally for linking the public to expert professionals and the knowledge resources of the University of California.