Lonza to Host Free Webinar on the New Regulatory Landscape for Sustainable Endotoxin Testing
June 3, 2020On 16 June, Lonza will host a free 60-minute webinar on the latest regulatory developments surrounding the use of the recombinant Factor C (rFC) assay for endotoxin detection in parenteral pharmaceuticals and implantable medical devices.
During the webinar, Allen L. Burgenson, Global Subject Matter Expert for Testing Solutions at Lonza Bioscience Solutions, will also discuss best practices and considerations for drug developers and quality control (QC) laboratories looking to implement the rFC assay.
Over the last few years, the biomedical industry and several horseshoe crab conservation organizations have been requesting that global pharmacopeias consider the animal-free rFC assay as a compendial bacterial endotoxin test (BET), equivalent to the gold standard animal-based Limulus Amebocyte Lysate (LAL) method. In response, the European, U.S., Japanese and Chinese pharmacopeias have recently announced plans to incorporate the sustainable rFC assay into upcoming revisions of their respective BET chapter or as a standalone chapter dedicated to the methodology.
In the webinar titled “The Compendia are ready. Are you? A More Sustainable Future for Endotoxin Testing”, Allen L. Burgenson will explore the following topics:
- The new regulatory landscape for the rFC assay
- The process of implementing the rFC assay in drug development and QC laboratories