Related Experiment Video
Updated: Jun 25, 2025

Optimization of In vitro Transcription Reaction for mRNA Production Using Chromatographic At-Line Monitoring
Published on: April 4, 2025
Regulatory Considerations for Producing mRNA Vaccines for Clinical Trials
1Albstadt-Sigmaringen University, Sigmaringen, Germany. schmida@hs-albsig.de.
None:
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 United States, 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.
More Related Videos
Related Concept Videos
Regulation of Expression at Multiple Steps
Regulation of Expression Occurs at Multiple Steps
Transcription results in the generation of precursor (pre-mRNA) that consists of both exons and introns, which needs further processing before being translated to a...
Regulated mRNA Transport
Nuclear Export of mRNA
Leaky Scanning

