Development & Production of Endotoxin under GMP for Human Clinical Research

This project was completed in August 2017.

Development & Production of Endotoxin under GMP for Human Clinical Research was a public-private partnership that enabled NIH to develop and produce a new strain of endotoxin under good manufacturing practices (GMP) conditions. Endotoxin is an essential tool to study the effects of inflammation which the NIH has provided at no cost to academic and pharmaceutical industry investigators since 1997. Endotoxin has been used to demonstrate proof of principle for the effects of inflammatory modulation therapies and, more recently, as a potent stimulus to enhance immune responses in trials of anti-cancer immunotherapy. The FNIH secured support to produce the next generation of GMP endotoxin, which is now available to qualified researchers.

Goals

  • Develop and produce a new strain of endotoxin under good manufacturing practices (GMP) conditions.
  • Facilitate the study the effects of inflammation for academic and pharmaceutical industry investigators.

Partners

Public-Sector Partners
National Cancer Institute (NCI)
NIH Clinical Center 

Private-Sector Partners
AstraZeneca UK Limited
F. Hoffman-La Roche Ltd
GlaxoSmithKline
Johnson & Johnson Services, Inc.
Pfizer Inc

*Provided financial or in-kind support for this program.

FNIH Contact

Development@fnih.org