Joint webinar – AFSA, HSI/India and USP India
Standard methods of vaccine safety testing often involve bacterial endotoxin tests based upon limulus ameboctye lysate (LAL). The use of LAL has come into question in recent years; LAL is derived from horseshoe crab blood thus its supply is unreliable by its very nature, particularly with populations of horseshoe crabs in decline which could further impact timely production of drugs and vaccines.
In this webinar co-organized by AFSA, HSI/India and USP India, we discussed how recombinant reagent technologies such as recombinant Factor C (rFC) assays offer a viable alternative to bacterial endotoxin testing. During the session, we aimed to raise awareness about rFC assays from a technical and regulatory perspective for Indian stakeholders, with speakers from India-based rFC suppliers and end users. Our speakers discussed assay characteristics, performance, equivalency to LAL, global regulatory acceptance status, and crucially, how the rFC assay presents an opportunity for sustainable transformation with a positive environmental impact without compromising on vaccine safety.
This webinar may be of particular interest for India-based regulators, safety assessors, pharmacopoeias’ experts and committees, national control laboratories, biopharmaceutical manufacturers and CROs, funding bodies and those in academia.
The webinar took place on August 22nd 2024, from 14.30 – 17.30 IST.
| Modified Agenda | ||
| Time (IST) | Topics | Speakers |
| 14:30 | Welcome and objectives | Harshita Mittal, Senior Manager, Strategy & Public Policy, HSI/India and Annu Uppal, Director, Scientific Affairs, USP India |
| 14:35 | Keynote lecture: Alternative approaches to LAL test, reasons for a change Presentation Slides | Ingo Spreitzer, Deputy Head of Section INF5 Microbiological Safety, Paul Ehrlich Institut, Germany |
| 15:05 | Substituting LAL with recombinant technologies. A global perspective Presentation Slides | Surat Parvatam, HSI India |
| Local end user’s experience with rFC testing | ||
| 15:20 | Ichor Biologics Presentation Slides | Sreedhar, Manager – Microbiology |
| 15:35 | Dr. Reddy’s Laboratories Presentation Slides | Venkata Ramana Kommagoni, Technical Lead, Microbiology -R&D |
| Local suppliers of recombinant kits | ||
| 15:50 | Sustainable Pharmaceutical Quality Control with Recombinant Factor C technology Presentation Slides | Ganesh Chaudhuri, Senior Application Specialist, bioMérieux Inc. |
| 16:05 | Moving towards sustainable BET testing Pyrogene® rFC assay Presentation Slides | Katrin Pauls, Market Development & Scientific Affairs Manager, Lonza |
| 16:20 | Endosafe® Trillium® Recombinant Cascade Reagent Validation Approach Presentation Slides | Alan Hoffmeister, Senior Global Scientific Portfolio Specialist, Charles River |
| Evolution of bacterial endotoxin test towards progressive science | ||
| 16:35 | USP’s Evolving Position on Bacterial Endotoxins Tests Presentation Slides | Leslie Furr, Senior Scientist II, General Chapters, USP |
| 16:50 | Keynote lecture: Bacterial Endotoxins Testing – Progressive Science and Sustainability Presentation Slides | Jay Bolden, Senior Director, Global Quality Laboratories, Eli Lilly and Company, USA |
| 17:20 | Closing remarks | Harshita Mittal, Senior Manager, Strategy & Public Policy, HSI/India and Annu Uppal, Director, Scientific Affairs, USP India |