title: Now that you want to take your HIV/AIDS vaccine/biological product research concept into the clinic: what are the "cGMP"?
abstract: The Division of AIDS Vaccine Research Program funds the discovery and development of HIV/AIDS vaccine candidates. Basic researchers, having discovered a potential vaccine in the laboratory, next want to take that candidate into the clinic to test the concept in humans, to see if it translates. Many of them have heard of "cGMP" and know that they are supposed to make a "GMP product" to take into the clinic, but often they are not very familiar with what "cGMP" means and why these good practices are so important. As members of the Vaccine Translational Research Branch, we frequently get asked "can't we use the material we made in the lab in the clinic?" or "aren't Phase 1 studies exempt from cGMP?" Over the years, we have had many experiences where researchers or their selected contract manufacturing organizations have not applied an appropriate degree of compliance with cGMP suitable for the clinical phase of development. We share some of these experiences and the lessons learned, along with explaining the importance of cGMP, just what cGMP means, and what they can assure, in an effort to de-mystify this subject and facilitate the rapid and safe translational development of HIV vaccines.
authors.affiliation: National Institutes of Health, National Institute of Allergy & Infectious Diseases, Division of AIDS, Vaccine Research Program, 5601 Fishers Lane, Rockville, MD 20892, USA.
authors.forename: Rebecca L
authors.initials: RL
authors.lastname: Sheets
authors.affiliation: National Institutes of Health, National Institute of Allergy & Infectious Diseases, Division of AIDS, Vaccine Research Program, 5601 Fishers Lane, Rockville, MD 20892, USA.
authors.forename: Vijaya
authors.initials: V
authors.lastname: Rangavajhula
authors.affiliation: National Institutes of Health, National Institute of Allergy & Infectious Diseases, Division of AIDS, Vaccine Research Program, 5601 Fishers Lane, Rockville, MD 20892, USA.
authors.forename: Jeffrey K
authors.initials: JK
authors.lastname: Pullen
authors.affiliation: National Institutes of Health, National Institute of Allergy & Infectious Diseases, Division of AIDS, Vaccine Research Program, 5601 Fishers Lane, Rockville, MD 20892, USA.
authors.forename: Chris
authors.initials: C
authors.lastname: Butler
authors.affiliation: National Institutes of Health, National Institute of Allergy & Infectious Diseases, Division of AIDS, Vaccine Research Program, 5601 Fishers Lane, Rockville, MD 20892, USA.
authors.forename: Vijay
authors.initials: V
authors.lastname: Mehra
authors.affiliation: National Institutes of Health, National Institute of Allergy & Infectious Diseases, Division of AIDS, Vaccine Research Program, 5601 Fishers Lane, Rockville, MD 20892, USA.
authors.forename: Stuart
authors.initials: S
authors.lastname: Shapiro
authors.affiliation: National Institutes of Health, National Institute of Allergy & Infectious Diseases, Division of AIDS, Vaccine Research Program, 5601 Fishers Lane, Rockville, MD 20892, USA. Electronic address: Michael.Pensiero@nih.hhs.gov.
authors.forename: Michael
authors.initials: M
authors.lastname: Pensiero
mesh_terms: D016915:AIDS Vaccines / Q000592:standards*; D002986:Clinical Trials as Topic; D033161:Government Regulation; D015658:HIV Infections / Q000517:prevention & control*; D006801:Humans; D057170:Translational Research, Biomedical / Q000331:legislation & jurisprudence / Q000592:standards*
chemical_list: D016915:AIDS Vaccines
keywords: Clinical trial; Good Manufacturing Practices; Investigational product; Manufacturing; Vaccine