Points To Consider: Demonstrating Comparability Between Recombinant and Lysate Reagent For BET Testing

09th September 2021 | 10.00 am EST | Karen Zink McCullough, Owner, Principal Consultant at MMI Associates and Veronika Wills, Manager, Technical Services At Associates of Cape Cod, Inc |BOOK FREE SEAT FOR THIS WEBINAR

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

Karen Zink McCullough is the principal consultant at MMI Associates, a firm focusing on GMP and Microbiology in the drug, biologics, cell therapy, and medical device industries, with a specialty in the Bacterial Endotoxins Test (BET). Ms. McCullough was the first to publish on the use of the BET as a replacement for the rabbit pyrogen test for small volume parenterals. She has published over 50 articles and book chapters, and is the editor of the book, “The Bacterial Endotoxins Test:  A Practical Guide.”   She is a well respected international speaker on GMP and the BET. Ms. McCullough is chairperson of the LAL Users’ Group, is a United States Representative to Working Group 2, TC 209 for the revision of ISO 14698, and is a member of the United States Pharmacopeia Expert Committee on Microbiological General Chapters. She holds a Bachelor’s degree in Bacteriology from Rutgers University and a Master’s degree in Molecular Biology from the University of Oregon.

Followed by Nicola Reid, Associate Director Product Management, Endotoxin Products at Charles River Laboratories

Nicola has over 20 years of experience with bacterial endotoxin testing and pharmaceutical microbiology. She has been involved in all aspects of the endotoxin assay, including the design and development of BET-specific instrumentation and software. Her work has led her to directing workshops and training courses, as well as lecturing internationally on a variety of BET-related topics including LAL methodologies, product validations, 21 CFR Part 11, and BET regulatory affairs.

Followed by Veronika Wills, Manager, Technical Services At Associates of Cape Cod, Inc

Veronika Wills manages the Technical Services group at Associates of Cape Cod, Inc. She joined the team in 2007 and thanks to her strong knowledge of biochemistry, microbiology and immunology, brings an expertise that is vital to ACC customers when it comes to technical support of testing complex samples, Low endotoxin recovery matrixes and troubleshooting of the Bacterial Endotoxins Test at all levels. Veronika speaks frequently at scientific conferences and seminars globally and is an established expert on endotoxin testing. Veronika holds a Master’s Degree in Biochemical Engineering from the Institute of Chemical Technology in Prague, Czech Republic.

Sponsored by Charles River and Associates of Cape Cod, Inc



About Charles River

The Microbial Solutions portfolio from Charles River brings you progressive products and services that deliver accurate, relevant, and reliable data to fuel confident decisions on product quality and contamination control. Our unique combination of Endosafe® endotoxin testing, Celsis® rapid microbial detection, and Accugenix® microbial identification and strain typing keeps your manufacturing operations running efficiently and smoothly, lowers your cost to manufacture, and protects your reputation. Learn more

About Associates of Cape Cod Inc


Specializing in chromogenic and turbidimetric reagent technologies, Associates of Cape Cod, Inc. (ACC) has been a global leader in endotoxin and (1→3)-ß-D-glucans detection products and services for more than 45 years. ACC pioneered LAL testing methodology and was the first FDA licensed company to manufacture LAL reagents; ACC has grown to be an internationally recognized leader in endotoxin detection.

Our worldwide headquarters are located in East Falmouth, Massachusetts. With a dedication to quality, ACC is certified to I.S. EN ISO 13485:2016 and ISO 13485:2016. We are FDA Inspected and operate DEA Licensed and CLIA-certified laboratories. Our endotoxin detection reagents, instruments and software are used within the Pharmaceutical, Medical-Device, Biotechnology, Compounding Pharmacy and Dialysis industries for quality control, product release and research. Our reagents are FDA licensed and can be used for testing in compliance with USP, EP and JP bacterial endotoxin test chapters, and our software is 21 CFR Part 11 Compliant.

ACC also operates a Contract Test Services (CTS) Laboratory which has specialized in testing for endotoxin and glucan contamination for over 30 years. Our CTS laboratory is GMP compliant, ISO registered and DEA licensed and is capable of handling all controlled drug substances except those included in Schedule 1. All testing services can be performed to FDA, USP, EP and/or JP regulatory guidelines. In addition to routine testing, our CTS Laboratory will customize endotoxin testing, troubleshoot difficult samples, develop and/or transfer LAL test methods, design and produce custom depyrogenation controls for oven validation and perform Low Endotoxin Recovery (LER) studies/protocols.

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