Recombinant Factor C Implementation For Endotoxin Testing.

07th November 2023 | 10:00am PST / 1:00pm EST / 6:00pm GMT / 7:00pm CET | Lindsey Silva, Ph.D. Director, Microbiology in Analytical Sciences at Genentech, Evelyn Der, Senior QC Scientist at Genentech, Kevin L. Williams, Endotoxin Sr Scientist at bioMérieux and Allen L. Burgenson, Global Subject Matter Expert, Testing Solutions Lonza Walkersville, USA |WATCH FOR FREE

This rFC 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

Recombinant Factor C Implementation Strategy For Endotoxin Testing Presented by Lindsey Silva, Ph.D. Director, Microbiology in Analytical Sciences at Genentech

Lindsey Silva, Ph.D, is a Director of Microbiology in Analytical Sciences at Genentech, a member of the Roche Group. Dr. Silva is a highly skilled analytical scientist with over 10 years of industry experience and a track record of developing and implementing technology to build agility for biological products. Our team is responsible for driving analytical innovation and QC microbiology solutions, including end-to-end microbial oversight of a growing oligonucleotide portfolio. Dr. Silva was previously responsible for virus clearance studies and the development of virus testing technologies to ensure the viral safety of biologics. Dr. Silva received her Bachelor of Science in Biology from UC Irvine, Ph.D. in Microbiology and Molecular Genetics from Harvard Medical School, and post-doctoral training from USC Keck School of Medicine. Dr. Silva is passionate about diversity and inclusion to drive innovation. Dr. Silva co-leads the SACNAS professional chapter at Genentech and is a board member of the non-profit ADDSTEAM.

Evelyn Der, Senior QC Scientist at Genentech

Recombinant Factor C Implementation Strategy For Endotoxin Testing. Evelyn Der, Senior QC Scientist at Genentech.

Evelyn Der has been with Genentech since 1999 and is currently a Senior QC Scientist.  Since being a part of the Global Technology Innovation Implementation group in 2021, Evelyn is one of the key participants supporting new technologies throughout the Roche Genentech QC network.  She is currently the global project lead driving the recombinant Factor C implementation at Roche Genentech and interacts closely with international functions for technical transfers and submissions.  She has over 25 years of experience in microbiology.  Evelyn graduated from the University of California, Berkeley with a Bachelor’s degree in Clinical Microbiology.  She holds professional certifications from the ASM, ASQ, and UCB in Microbiology, pharmaceutical GMPs, and Regulatory Affairs.

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

Recombinant Factor C Implementation Strategy For Endotoxin Testing. 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

Recombinant Factor C Implementation Strategy For Endotoxin Testing. 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 ensure 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 products. 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 PyroTecTM PRO Automated Endotoxin Testing solution, which is the industry leader in automated endotoxin detection.

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