Enhancing process consistency and lessening variability is pivotal for enduring success in biopharmaceutical manufacturing. Variability can stem from various sources; one frequent source is inconsistencies in the composition of cell culture media and supplements from one batch to another. Particularly, unexpected impurities in raw materials, as well as natural variability in non- chemically defined components, may result in less-than-ideal bioprocess outcomes.
Owing to this risk of variability, there has been an increasing focus on using chemically defined media and supplements in biopharmaceutical production. However, even chemically defined raw materials may contain unexpected impurities which could affect productivity. Hence, non-chemically defined components remain a valuable alternative that developers should contemplate, particularly when measures to reduce risk are employed. These involve selecting a supplier with strict production controls and undertaking comprehensive analyses to understand which components a cell culture process is most sensitive to, then implementing suitable mitigation measures.