Antibody production relies on a broad range of raw materials. Most of these raw materials are used in various industrial applications and their specifications have not been developed with antibody production in mind. Chemical or physical characteristics, contaminants and impurities may diverge between lots and can lead to variability in performance of these raw materials in antibody production, even though these raw materials work well in other applications. This leads to process inconsistencies, yield loss, and can even affect the characteristics and quality of the final drug product.
The Biopharma industry has recognized the importance of raw material consistency and efforts have been made to better understand the requirements for raw materials in bioprocessing. Raw material suppliers are using the learnings of the Biopharma industry and started developing application-specific products for the biopharma industry, which reduce the risk of performance variations. One example is BASF’s Kolliphor® P188 Bio, which was developed to address performance variability in cell culture. We would like to share our learnings from developing raw materials with Biopharma in mind and give an outlook on how raw material suppliers can support the Biopharma industry to achieve more robust and efficient processes.
