Cultivation Technology Considerations Within the Cell-Based Scale-Up Continuum

Culture-based production of cell-derived biologics and whole-cell therapies continues to permeate the biopharmaceutical market. In 2019, seven of the ten best-selling drugs were biologics. Pharmaceutical organizations are rapidly developing new culture-based therapeutics and techniques, producing a dynamic range of biologically relevant products, from therapeutic antibodies and proteins to recombinant hormones and clotting factors.

Register for this webinar to learn how to choose the right cell-based production platform to take biologic drugs from early development through manufacturing and scale-up. Attendees will also learn why agitation-based bioreactors aren’t fit for every application.

Regenerative drugs, mesenchymal stromal cell (MSC)-derived materials and engineered tissue production are also emerging fields, employing living cells as medicine. As science’s understanding of disease expands, biologically-based therapies engineered from living mammalian cells will also increase.

The scale of clinical cell-based therapy is vast, ranging from personalized, benchtop culturing platforms to multi-liter bioprocess techniques. Throughout the scale-up continuum, it is paramount to adhere to good manufacturing practice (GMP) quality standards. Production standards often focus on agitation-based bioreactors, yet many cell-culture-based production techniques continue to rely on adherent cell lines as a reliable means to produce consistent yields.

Facilities expanding highly specialized cell lines for use in therapies require scale-ups that avoid the shear-damage and stress that can occur when using bioreactors. For this reason, small and mid-size facilities have an increased need for static, precision-controlled culture incubators with an array of sizes to facilitate small, personalized medicine assays through large-capacity units that house gentle agitation machinery for biological expression.

In this webinar, the featured speaker will explore different cell expression platforms that enable various cell-based manufacturing within the small- and medium-range scale of production. Learn how the design of the incubation systems should support both clinical and pharmaceutical applications, starting with research and leading to development, manufacturing and scale-up. With respect to GMP, incubator technology must include algorithmic control systems and safeguards designed to protect the cell culture or cell-expressed product, particularly when associated with direct human application such as stem cells, regenerative tissue processes or autologous cell culture.

Register for this webinar to hear an expert from PHCbi discuss the “other side” of cell and biologic production that doesn’t require stirred bioreactors.

Speaker

Holly Hattaway, Incubator Product Specialist, PHC Corporation of North America

After graduating from Northeastern Illinois University with a bachelor’s in biology, Holly spent several years at Northwestern University’s department of cellular biology researching HIV and cancer tumor growth at the Feinberg School of Medicine. In the fall of 2019, Holly joined the PHC family as a product specialist working with the PHCbi line of incubators and cell culture products. She and the PHC team strive to bring innovative, scientific technology to scientists everywhere.

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