title: Immune monitoring: it's prudent to adopt current quality regulations.
abstract: The United States Food and Drug Administration and its international governmental counterparts provide strict guidelines for product manufacture, quality control and clinical practice, but no regulations exist for immune monitoring. This is not surprising because it is a relatively new field that is increasingly applied in clinical trials of immunotherapy. Immune monitoring is experimental in nature, usually performed in an R&D laboratory, and is typically not integrated into an organization's quality assessment system. With the proliferation of immunotherapy studies and immunogenicity testing, regulatory agencies will progressively increasingly demand that quality regulations be applied to immune monitoring in the future. Here, I highlight the relevance of existing regulations, which, I believe, should be prospectively tied into the development and performance of immune monitoring methods.
authors.affiliation: Quality Control and Immune Monitoring, Northwest Biotherapeutics, Inc., Bothell, WA 98021, USA. rite2gopi@yahoo.com
authors.forename: Gopi
authors.initials: G
authors.lastname: Shankar
mesh_terms: D017277:Drug Approval / Q000331:legislation & jurisprudence*; D004345:Drug Industry / Q000331:legislation & jurisprudence* / Q000592:standards; D019983:Guideline Adherence / Q000331:legislation & jurisprudence* / Q000592:standards; D006801:Humans; D007167:Immunotherapy / Q000331:legislation & jurisprudence*; D007880:Legislation, Drug; D015166:Monitoring, Immunologic / Q000379:methods* / Q000592:standards*; D011786:Quality Control; D015203:Reproducibility of Results; D014481:United States