On 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
The Compendia are ready. Are you? A More Sustainable Future for Endotoxin Testing
Presenter: Allen L. Burgenson
Moderator: Travis Wallace, Scientific Support Specialist, Lonza Bioscience Solutions
Tuesday, 16 June 2020
- 8 AM PDT (Los Angeles)
- 11 AM EDT (New York)
- 4 PM BST (London)
- 5 PM CEST (Berlin)
Further information can be found on Lonza’s PyroGene™ Recombinant Factor C Assay web page. By registering interest in the webinar, participants will also receive a link once it is available to view the webinar “on demand” via the Lonza website.
At Lonza, we combine technological innovation with world class manufacturing and process excellence. Together, these enable our customers to deliver their discoveries in the healthcare, preservation, and protection sectors.
We are a preferred global partner to the pharmaceutical, biotech and specialty ingredients markets. We work to prevent illness and promote a healthier world by enabling our customers to deliver innovative medicines that help treat or even cure a wide range of diseases. We also offer a broad range of microbial control solutions, which help to create and maintain a healthy environment.
Founded in 1897 in the Swiss Alps, Lonza today operates in 120 sites and offices in more than 35 countries. With approximately 15,500 full-time employees, we are built from high-performing teams and of individual employees who make a meaningful difference to our own business, as well as the communities in which we operate. The company generated sales of CHF 5.9 billion in 2019 with a CORE EBITDA of CHF 1.6 billion.