rFC: from scientific breakthrough to implementation
The detection of Bacterial Endotoxins in parenteral pharmaceuticals and medical devices is critical to patient safety and has traditionally relied on the Limulus Amebocyte Lysate (LAL) method. However, with the introduction of recombinant Factor C (rFC) and the adoption of USP Chapter <86>, the industry is taking a major step towards reducing the reliance on animal-derived materials while simplifying and modernizing endotoxin testing.
In this webinar, our expert speakers - Jeak Ling Ding, Emeritus Professor (Department of Biological Sciences, National University of Singapore) and Katie Carroll, Manager, QC Microbiology (QuVa Pharma) - will take you through the journey from the discovery of rFC to its implementation, providing valuable insights into the benefits of rFC and the method validation process.
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About our speakers:
Professor Jeak Ling Ding is a world-renowned pioneer in the field of molecular biotechnology and currently Emeritus Professor at the Department of Biological Sciences, National University of Singapore (NUS). Her research focuses on innate immunity in host-pathogen interaction, antimicrobial defense and anticancer immunomodulation. Her work has resulted in around 300 scientific publications and 19 patents, along with a host of awards and honors, including most recently her induction into the Singapore Women’s Hall of Fame. Professor Ding’s expertise in molecular biotechnology led to the genetic engineering of horseshoe crab recombinant Factor C (rFC), which has been available since 2003 and is utilized worldwide for endotoxin detection.
Katie Carroll is the QC Microbiology Manager at QuVa Pharma, a 503b compounding facility located in the United States. Katie has been working in the field on microbiology for seventeen years. In 2021, she was hired by QuVa as a microbiologist working on the bench in the endotoxin laboratory. She advanced her career within the organization by successfully implementing new and robust testing methodologies, including the bioMerieux ENDONEXTTM .