Biochemicals/Raw Materials

Application of animal-free recombinant bioactive protein supplements to improve the performance of cell-based viral vaccine production

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The development and regulatory approval of continuous cell lines for manufacturing viral vaccines has brought numerous benefits to production processes. We and others have contributed to upstream advances by improving cell culture media with the development of animal-free and chemically-defined recombinant protein supplements. The supplements developed include recombinant insulin-like growth factor-I (LONG®R3IGF-I), epidermal growth factor (LONG®EGF), transforming growth factor-α (LONG®TGF-α), transferrin (CellPrimeâ„¢ rTransferrin AF), and albumin (CellPrime â„¢rAlbumin AF-G or -S). Extensive literature on the action of these bioactive proteins…

November 9, 2010

Working Toward Animal-Free Processing

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    Biological therapeutics is one of the fastest growing segments of the pharmaceutical industry — so much in fact that the overall cell culture media and supplements market used in bioprocessing applications is reportedly near $800 million (1). An increasingly important trend in cell culture is risk reduction throughout the supply chain, including a stringent focus on key raw materials. Accordingly, the industry has increasingly adopted animal-component-free materials to mitigate concerns over safety, transmissible spongiform encephalopathies, and other contaminations.…

November 1, 2010

Is Bovine Albumin Too Complex to Be Just a Commodity?

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    Albumin is the most abundant serum protein. It serves several functions in vivo: e.g., binding and transport of fatty acids, hormones, and metal ions; maintenance of osmotic pressure and pH; and binding of exogenous toxins and products of lipid oxidation (1). Over time, development of large–scale purification methods have translated those functions into diagnostic, cell culture, and microbiological applications. It is important to note, however, that purification procedures can promote molecular changes and thereby add to the already…

April 1, 2010

Changes in Raw Material Sources from Suppliers

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    Maintaining the supply chain of single-source raw materials is of utmost importance for a biopharmaceutical company’s manufacturing operations. As often happens, a supplier will notify its customer of process changes that might affect the quality or properties of supplied materials. Occasionally, a supplier might notify the customer of substitutions in its own supply chain or other changes in the source of its own raw materials. Customers must conduct appropriate testing using the “new†raw material(s) to ensure acceptable…

April 1, 2010

Is Bovine Albumin Too Complex to Be Just a Commodity?

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    For decades, the complexity of albumin has been researched extensively, yet many manufacturers and users of the protein have treated it more as a commodity. Because albumin has been readily available, suppliers and purchasers alike have frequently relied on more obvious measures of “purity†and other minimal release criteria to make their decisions. If a lot does not perform well in practice, the typical supplier’s response has been to investigate the manufacturing process for deviations, then correct them…

February 1, 2010

Nutrient Supplementation Strategies for Biopharmaceutical Production, Part 3

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    Scale-up studies are needed for assessing cell culture production system options and for testing nutrient supplementation techniques as well. With the many supplementation options available, choices need to be made as early in product development as possible because advantages can change with scale. One published fed-batch scale-up study testing from 3 L up to 2,500 L highlights items to be considered in addition to the nutrient supplementation process such as the impact of pH and CO2 control (1).…

January 1, 2010

Nutrient Supplementation Strategies for Biopharmaceutical Production, Part 2

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Some of the numerous feeding strategies are more appropriate than others for certain types of cell culture production systems. Once a nutrient supplement has been identified as described in Part 1 of this three-part review (1), a supplementation strategy must be chosen. Supplementing at too great a rate may expose log-phase cells to stresses such as increased osmolality and lactate levels that would inhibit biomass expansion. But inadequate supplementation can lead to early apoptosis through rapid depletion of selected important…

December 1, 2009

A Risk-Based Aproach to Establishing Animal-Component–Free Facilities

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Bovine spongiform encephalopathy (BSE) and its potential to affect humans emerged as a concern in the 1990s. So suppliers of many essential animal-sourced components used in cell culture and fermentation processes became concerned about the potential for material contamination with prions. Viruses also can be present in raw materials derived from animal origins. Many important drug and vaccine products are made by mammalian cell culture or bacterial fermentation, so their biological safety is paramount. However, it is very difficult to…

December 1, 2009

Nutrient Supplementation Strategies for Biopharmaceutical Production

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Cell-culture–related in vitro recombinant protein production is currently a $70-billion/year business. In 2007, biotech drug sales grew by 12.5%, twice as fast as standard pharmaceuticals (1). Current ongoing efforts to maximize productivity in both time and volume directly affect the scale and capital investment required for a bioreactor suite. As cells reach higher concentrations more quickly while each cell pumps out more product than ever before, the number and scale of bioreactors can be reduced. To that end, not only…

November 1, 2009

Using Innovation to Drive Competitive Advantage

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    Figure 1: () STOCKXPERT (WWW.STOCKXPERT.COM) After spending decades as the “sleepy†segment of the biopharmaceutical industry, vaccines are now seen as one of its highest growth segments. Major pharmaceutical companies — Novartis AG (www.novartis.com) and Pfizer, Inc. (www.pfizer.com), for example — are aggressively entering this area. Those already in it are expanding capacity and increasing business development activity. Indeed, access to the vaccines business was a major driver of Pfizer’s acquisition of Wyeth Pharmaceuticals (www.wyeth.com) (1). Several factors…

September 1, 2009