Detection of bacterial endotoxins is a critical quality attribute of parenteral pharmaceuticals and medical devices. Bacterial endotoxins are cell wall components of Gram-negative bacteria, ubiquitous in nature, difficult to destroy and can cause pyrogenic responses or worse.
We are at a generational change in bacterial endotoxins test method options. Creating the infrastructure to enable broader use of recombinant reagents advances the science while maintaining the safety and quality of medicines. Recombinant reagents are derived from established biotechnology principles which begin with the same mechanism of action as the natural protein derived from horseshoe crabs; the detection of bacterial endotoxins by the Factor C protein. Recombinant reagents also afford improvements in quality, supply chain, and sustainability.
The USP Microbiology Endotoxin and Pyrogens Subcommittee developed a recombinant reagent bacterial endotoxins test chapter which is based on the underlying science, and data from the peer-reviewed literature, sponsor and supplier validations, and ring study trials.
The presentation will provide a general overview of the Subcommittee work, and detailed information regarding the recombinant bacterial endotoxins chapter, associated guidance, and the public health reference standard endotoxin.
Presented by
Jay Bolden Senior Director
Eli Lilly and Company Global Quality Laboratories
Mr. Jay Bolden is a Senior Director in the Eli Lilly and Company Global Quality Laboratories and a member of the United States Pharmacopoeia Microbiology Expert Committee. He is a bacterial endotoxins subject matter expert and leads a team with global QC oversight for developing, validating, transferring, and troubleshooting endotoxin, microbiology, QPCR and ELISA methodologies. Jay holds a B.S. in Biology and an Environmental Studies certificate from Indiana University. Jay has over 25 years of industry experience in development, process and laboratory microbiology, and microbiology laboratory leadership. Jay has authored a book chapter and many peer-reviewed articles on endotoxin testing and recombinant reagents and is a highly sought-out speaker in industry pharmaceutical quality control forums.
Allen L. Burgenson Global Subject Matter Expert, Testing Solutions
Lonza
Allen L. Burgenson has over 40 years of experience as a Microbiologist 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 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), a member of the Horseshoe Crab Working Group of the International Union for the conservation of Nature (IUCN), and the immediate past president of the Capital Area Chapter of the Parenteral Drug Association (PDA). 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.
Veronika Wills Director, Global Technical Services
Associates of Cape Cod, Inc
Veronika Wills, Director of Global Technical Services at Associates of Cape Cod, Inc., has been an integral part of the team since 2007. With her extensive knowledge in biochemistry, microbiology, and immunology, Veronika leads a global team that provides critical technical support for testing complex samples, addressing low endotoxin recovery matrices, and troubleshooting the Bacterial Endotoxins Test at all levels.
An established expert in endotoxin testing, Veronika frequently speaks at scientific conferences and seminars worldwide, sharing her insights and expertise. She holds a Master’s Degree in Biochemical Engineering from the Institute of Chemical Technology in Prague, Czech Republic.
Followed by a live Question and Answer Session
Sponsored by
About Lonza
Lonza is the preferred global partner for 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.
About Associates of Cape Cod, Inc
Fifty years ago, ACC (Associates of Cape Cod, Inc.) revolutionized the endotoxin detection industry by pioneering LAL testing methodology. We continued to innovate with the first and only FDA-cleared and CE marked rapid screening test for invasive fungal infections (IFI), Fungitell®.
Today, we are recognized as an international leader in endotoxin and glucan detection. Our latest offering, PyroSmart NextGen®, is a recombinant technology that replicates the LAL enzyme cascade without animal content.
Our global headquarters are located in East Falmouth, Massachusetts, USA. In Europe, our office in Knowsley, UK, established 30 years ago, is supported by our distribution warehouse in Nijverdal, NL.
As an international leader, our legacy and commitment to quality stands, as we continue to provide Protection Through Detection™.
