Christian Lotz studied Physical Chemistry at the University of Bochum Germany and did his doctorate in Physical Chemistry at the University of Essen in Germany. He started his Industry career at Lipoid GmbH, a GMP manufacturer of parenteral grade phospholipids, in the sales department with technical and regulatory support functions. Since April 2015 Christian is working as BD Director EMEA and Technical Support and lately as General Manager EMEA at Pfanstiehl, world’s leading manufacturer of low endotoxin and high purity GMP parenteral grade carbohydrate and amino acid based excipients, providing commercial and technical support to the EU customer base. Christian has 24 years of experience in GMP relevant sourcing, marketing and technical support functions for pharmaceutical raw materials.
Polysorbate degradation is a persistent challenge in biologics formulations, often driven by trace metals contamination such as iron (Fe) and copper (Cu) often found in excipients. Pfanstiehl's highly processed & purified excipient grade amino acids , refined to remove trace metals to single-digit parts per billion, offer a solution. In a customer-developed case study, the use of Pfanstiehl's High Purity Low Endotoxin Low Metals L-Histidine successfully prevented polysorbate degradation under high-temperature accelerated stability conditions, demonstrating its effectiveness in preserving surfactant integrity. The presentation will also cover some aspects of challenges of formulating complex Biologics.