Why High Purity Of Amino Acids Is The Foundation For Achieving Reliable Media Performance

By Dr. Christian Kessler, Director of Amino Acids and Peptides, Evonik

Biopharma processes continue to raise the bar for the use of chemically defined amino acids across various manufacturing and clinical applications. Derivatives of amino acids such as dipeptides and keto acids are increasingly preferred to help minimize batch-to-batch variation, reduce overdosing risks and boost productivity. In particular, functionally superior dipeptides are now well established for their ability to substitute free glutamine, cysteine/cystine or tyrosine in basal media or concentrated feeds without having any adverse effect on titer or yield. Accordingly, such boosters are now routinely utilized by the biopharma industry to overcome typical challenges encountered in cell culture media during the development and production of their antibody, protein or vaccine-based products.

However, the primary foundation for reliable media performance remain natural amino acids manufactured at the highest possible standards for quality and purity. As a minimum, amino acids used in biopharma processes must be animal-origin free, governed by strict change control policies and utilize precisely controlled processes to eliminate impurities such as endotoxins and heavy metals.