A novel human-cell based pyrogen test
- In: G37 - Manufacturing and good manufacturing practice IPS (part 1) on Wednesday, 5 September 2007, 9:00-11:45
- At: Beijing (China) (2007)
- Type: Presentations + Posters
- By: HANSEN, Erik Wind (University of Copenhagen, Copenhagen, Denmark)
- Co-author(s): Timm, Michael (University of Copenhagen, Copenhagen, Denmark)
All drugs, biologics and media that are intended for injection or implantation into humans, as well as the equipment used to introduce them, need to be tested to ensure that pyrogenic contaminants are within acceptable limits of safety. There are two pharmacopoeia-approved methods to do this: the LAL test or the Rabbit Pyrogen Test (RPT). Both of.. The access to the whole abstract and if available the presentation file is available to FIP members and to congress participants of that specific congress.