Webinar: Adventitious egg-based agents testing
Adventitious agents are defined by the World Health Organization as microorganisms that may have been unintentionally introduced into the manufacturing process of a biological medicinal product. These include bacteria, fungi, mycoplasma/spiroplasma, mycobacteria, rickettsia, protozoa, parasites, transmissible spongiform encephalopathy agents, and viruses. Vaccines produced in biological materials—such as eggs—require thorough characterization of starting materials for inherent and adventitious agents.
This PATH-organized webinar features speakers who are experts in the field and helps manufacturers understand recent regulatory guidelines and analytical and cell culture technologies used in the vaccine industry for adventitious egg-based vaccine production of viral vaccines.
Speakers include:
- Lakshmi Khandke, Sr. Program Advisor, Vaccines, CMC, Center for Vaccine Innovation and Access, PATH
- Rich Hjorth, Independent Consultant
- Cynthia Allen, Senior Scientific Evaluator, Vaccine Quality Division, Biologic and Radiopharmaceutical Drugs Directorate, Health Canada
- Jennifer Moro, Senior Manager, In Vivo Biosafety Group, Charles River Laboratories
- Stefanie Bendfeldt, Scientific Officer, Biosafety R&D, Charles River Laboratories
- Georges Aboujaoudé, Virologist, Charles River Laboratories
- Jens-Peter Gregersen, Independent Biomedicines Consultant
- Rudolf Zirwes, Charles River Laboratories
Publication date: November 2023
Available materials
-
English
-
Day 1: Intro and egg-based vaccines
9.8 MB PPTX
-
Day 1: Regulatory
5.1 MB PPTX
-
Day 1: Test for extraneous agents in cell culture
16.2 MB PPTX
-
Day 1: Avian leukosis test
5.6 MB PPTX
-
Day 2: Intro and neutralization of vaccine virus
9 MB PPTX
-
Day 2: Facilities
10.5 MB PPTX
-
Day 2: Equipment qualification and method validation
5.3 MB PPTX
-
Day 2: Future directions and considerations
7.8 MB PPTX
-
Day 1: Intro and egg-based vaccines
9.8 MB PPTX
-
English