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).…
Author Archives: Richard Fike
Nutrient Supplementation Strategies for Biopharmaceutical Production, Part 2
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…
Nutrient Supplementation Strategies for Biopharmaceutical Production
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…