title: Considerations for Producing mRNA Vaccines for Clinical Trials.
abstract: The approval of clinical trials by the competent authorities requires comprehensive quality documentation on the new drug to be used on the clinical trial participant. In the EU quality data is summarized as Investigational Medicinal Product Dossier (IMPD), in the USA as Investigational New Drug (IND) Application. For that, several preconditions concerning production, quality control, and assurance have to be fulfilled. Here, specific requirements related to mRNA vaccines are addressed on the basis of European standards.
authors.affiliation: University of Applied Sciences Albstadt-Sigmaringen, Anton-Günther-Str. 51, 72488, Sigmaringen, Germany. schmida@hs-albsig.de.
authors.forename: Andreas
authors.initials: A
authors.lastname: Schmid
mesh_terms: D000818:Animals; D002986:Clinical Trials as Topic / Q000379:methods; D015507:Drugs, Investigational / Q000008:administration & dosage; D005062:European Union; D006801:Humans; D011786:Quality Control; D012333:RNA, Messenger / Q000276:immunology*; D014612:Vaccines / Q000276:immunology*
chemical_list: D015507:Drugs, Investigational; D012333:RNA, Messenger; D014612:Vaccines
keywords: Clinical trial; Drug substance; IMPD; Investigational medicinal product; Specification; mRNA