BPI Europe 2025: Overcoming Raw Material Variability in Bioprocessing
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. Two examples are BASF’s Kolliphor® P188 Bio and Kolliphor® P188 Cell Culture, which was developed to address performance variability in cell culture. To better meet the needs of the growing biopharma industry, we will introduce Kollipro™ Urea Granules, a compendial GMP product for use in inclusion body solubilization and chromatography column cleaning. The granules allow for improved flowability, resulting in reduced agglomeration, and decreased preparation and handling time.
Visit us to join our poster sessions, held by our expert Dominik Hermann Schreiber, available Tuesday, May 13th - Thursday, May 15th:
- "Next-Generation Flocculants for Downstream Intensification"
- "Custom Poloxamers for shear stress protection, formulation and other applications: BASF GMP small scale manufacturing capabilities at Wyandotte (USA)"