Biopharmaceutical manufacturers are required to ensure drug product quality attributes for patient safety. Strong contamination control strategies should be considered early in process design and have a direct influence on production environment and equipment selection. Sampling at each step in your process is a critical component in maintaining a contamination control strategy. A case study will be presented that demonstrates a closed, robust sampling solution capable of maintaining a sterile flow path when challenged with Brevundimonas diminuta. The sampling option you select can help support your goal to achieve a closed process improving your risk mitigation strategy and product safety.
Alex Chalmers is an R&D Scientist III in the Virology & Microbiological Sciences group and has over 10 years of experience in microbiology. His most recent work has focused on the biopharmaceutical industry, developing products and methods for microbial retention, microbial integrity of single-use products, bioburden and sterility testing and preservative efficacy. He has authored publications covering various aspects of rapid microbial detection and antibiotic susceptibility testing. He earned a BS in Biology and MS in Biotechnology from the University of Massachusetts.
Regulatory Affairs Advocate
Janmeet Anant serves as a Regulatory Affairs Advocate for our company. Over the last few years, Janmeet has been focused on supporting the areas of aseptic processing and single-use technologies. Janmeet serves as an Executive Board Member on the Bioprocess Systems Alliance (BPSA) and is a voting member of the ASTM and ASME-BPE standard setting organizations. He has 20 years of experience as a supplier for the biopharmaceutical industry, starting in a technical applications role focused on chromatography, and moving through sales, marketing and most recently regulatory support. Janmeet has a Bachelor’s of Science degree in Chemistry and a Ph.D. in Pharmacology.