Variability, Limits, and Other Considerations for the Next Generation of Pyrogen and Endotoxin Testing

Presented by Karen Zink McCullough, Owner, Principal Consultant at MMI Associates

Followed by 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.

Timothy Francis, Senior Technical Specialist for the LAL Division of FUJIFILM Wako Chemicals U.S.A. Corporation

Timothy Francis is the Senior Technical Specialist for the LAL Division of FUJIFILM Wako Chemicals U.S.A. Corporation. He oversees the technical training of the LAL division’s distributor network and has authored many editorials on the BET in several publications. He comes into the technical specialist role with 5 years of experience teaching the natural sciences at the university level. He holds a master’s degree in curriculum and instruction in natural science and a bachelor’s degree in biology.

Sponsored by Lonza and FUJIFILM

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.

About FUJIFILM
At FUJIFILM Wako Chemicals U.S.A. Corporation, we are dedicated to advancing the field of bacterial endotoxin detection by providing world class reagents and support. With our relentless commitment to quality, our constant pursuit of new technologies and innovations, and our global network of 40+ distributors, we are proud to contribute to public health and safety around the world.
After establishing a sales office in Dallas, Texas, in 1981, we grew significantly in the U.S. and in 1989, relocated our corporate headquarters and manufacturing facility to Richmond, Virginia. In 2012, FUJIFILM Wako culminated three decades of research and development by introducing our PYROSTAR™ ES-F series to the global markets. The PYROSTAR™ ES-F series offers a simple, accurate platform for the detection of bacterial endotoxin, with a high level of accuracy, sensitivity, and flexibility. This endotoxin-specific LAL reagent is accompanied by a suite of complementary products to offer a complete solution for your endotoxin testing needs. When partnering with our LAL Division, you receive personal attention from a team of specialists dedicated to your success. We look forward to providing you with superior service and supporting your laboratory in maintaining the utmost level of quality control.