Sustainability In Bacterial Endotoxin Testing

A Holistic Approach to Conservation and Recombinant Technology

December 10th, 2020 • 6:30 a.m. PT, 9:30 a.m. ET

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Overview

Horseshoe crabs in the United States are regulated and monitored carefully. They are not endangered, in fact, in many areas populations are growing considerably. The biomedical industry has a pivotal role to ensure the conservation and future sustainability for this ancient creature. Brett will walk us through the current conservation and population review of the horseshoe crab and how industry can help with future conservation and sustainability efforts.

Veronika will look at the role recombinant reagents are likely to play in the future of endotoxin testing. The current regulatory landscape with respect to recombinant technologies is not at all harmonious, and therefore the regulatory framework and requirements for implementing recombinant technologies as a new method vary. As it appears, the industry is somewhat cautious in adopting a new technology for such a critical test.

Veronika will also provide a review of the current comparability data demonstrating the performance of recombinant technologies versus the gold standard test – LAL based reagents.

In this webinar you’ll learn:

• Overview of current conservation/sustainability status of the horseshoe crab population in the US

• New developments in recombinant technologies

• Update on the regulatory framework around recombinant reagents

• Sharing comparability data

Who should attend:

• Senior Microbiologists

• Lead Scientists

• Laboratory Managers

• QA Specialists

• Heads of Quality

Presenters

Presenter
Veronika Wills
(Presenter)
Technical Manager
Associates of Cape Cod, Inc.(ACC)
View Biography
Presenter
Brett Hoffmeister
(Presenter)
LAL Production Manager,
Associates of Cape Inc. (ACC)
View Biography
Presenter
Mike Auerbach
(Moderator)
Editor-in-Chief,
American Pharmaceutical Review