RFC Implementation Strategy For Endotoxin Testing

The webinar will provide insight into the regulatory landscape for recombinant Factor C (rFC) implementation as a sustainable endotoxin test method. A range of considerations for method validation activities to ensure health authority acceptance will be covered in the webinar including rFC method validation requirements as an alternative non-pharmacopeial method, rFC method implementation considerations for pharmaceutical water and product testing, and rFC method transfer strategy for QC network adoption.

Presented by Lindsey Silva, Ph.D. Director, Microbiology in Analytical Sciences at Genentech

Evelyn Der, Senior QC Scientist at Genentech

Followed by Kevin L. Williams, Endotoxin Sr Scientist at bioMérieux

Kevin studied microbiology at Texas A&M University and has worked in the pharmaceutical field for 35 years. The bulk of his career was spent at Eli Lilly & Company (30 years) developing QC tests for microbial and endotoxin detection. Kevin‘s current role at bioMérieux as a Senior Scientist focuses on endotoxin science, including Low Endotoxin Recovery method development. Kevin has also helped set up a dedicated endotoxin service laboratory in the USA for hold-time studies, LER root cause analysis and endotoxin demasking protocol development. He is the author of Endotoxins 2nd Edition (Marcel Dekker, 2001), Microbial Contamination Control in Parenteral Manufacturing (CRC Press, 2004) Endotoxins 3rd Edition (Informa Healthcare, 2007).

Allen L. Burgenson, Global Subject Matter Expert, Testing Solutions at Lonza

Allen L. Burgenson has over 35 years of experience in industries regulated by the FDA, including Foods, Drugs, Biologics, Medical Devices, and Cos­metics. He has worked in R&D, QC, QA, Regulatory Affairs, and now Marketing as an SME for endotoxin detection. Allen is involved in several scientific organizations including, the immediate Past-Chair of the Horseshoe Crab Advisory Panel for the Atlantic States Marine Fisher­ies Commission (ASMFC) and the immediate Past-President of the Capital Area Chapter of the Parenteral Drug Association (PDA). He was Chair of the 2004 PDA Annual Meeting.  He is a co-author of three PDA Technical Reports including, TR-50 and 51 regarding Mycoplasma detection and filtration, and TR-82 regarding Low Endotoxin Recovery (LER). Allen also contributed to USP Informational Chapter <1228.5> on Endotoxin Indicators. Allen has a BA in Microbiology from Rutgers University and an MS in Biotechnology Management from the University of Maryland

Sponsored by bioMérieux and Lonza

About bioMérieux

With more than 50 years of pioneering diagnostics, the people of bioMérieux understand the challenges you face when it comes to ensuring product quality and are proud to offer the most comprehensive portfolio of solutions for microbiology Quality Control of biopharmaceuticals and ATMPs.  Choosing the right microbiology diagnostic can boost efficiency with in-processes testing and automation simplifies the testing processes, reduces human error, and helps ensures data integrity. Rapid, simple, at-line testing of key parameters allows in-process tests to be performed closer to the production environment and provides certainty that your manufacturing process is secure.

About Lonza

Lonza is the preferred global partner to the pharmaceutical, biotech and nutrition markets. We focus on enabling treatments that prevent illness and support healthier lifestyles. We optimize scientific innovation and manufacturing technology to enable our customers to serve their patients and consumers. Our comprehensive range of testing solutions supports your efforts in pyrogen and endotoxin testing of raw materials, in-process samples and manufactured product. No matter where you are in your process, Lonza’s testing products optimized with our world-class software and hardware solutions and supported by our experts will help streamline your workflows and meet regulatory requirements for injectable drugs and implantable medical devices, including for new modalities used in modern vaccines and biologics. We can help answer your questions about endotoxin testing whether you use qualitative gel clot, quantitative turbidimetric or quantitative chromogenic LAL-based assays, or want sustainable recombinant factor C endotoxin testing, or sustainable pyrogen testing. Our BioScience Division provides a large portfolio of testing solutions to support the pharmaceutical and medical device industries, including classical LAL assays (Pyrogent® gel clot, Pyrogent-5000® kinetic turbidimetric, and KineticQCL® kinetic chromogenic assays), and sustainable recombinant Factor C (PyroGene®) assays for endotoxin detection.  We provide Monocyte Activation Assays to detect pyrogenic substances as a sustainable alternative to the Rabbit Pyrogen Test.  We also supply the industry-leading MODA software for laboratory data that eliminates paper from the process, as well as the PyroTec^TM PRO Automated Endotoxin Testing solution, which is the industry leader in automated endotoxin detection.