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.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
References
European Commission (2010) EU guidelines to good manufacturing practice - medicinal products for human and veterinary use - Annex 13 Investigational Medicinal Products. http://ec.europa.eu/health/files/eudralex/vol-4/2009_06_annex13.pdf. Accessed 4 Sep 2015
European Medicines Agency (2006) Guideline on the requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials. http://ec.europa.eu/health/files/eudralex/vol-10/18540104en_en.pdf. Accessed 6 Aug 2015
European Medicines Agency (2012) Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials. http://ec.europa.eu/health/files/eudralex/vol-10/2012-05_quality_for_biological.pdf. Accessed 6 Aug 2015
Milligan JF, Groebe DR, Witherell GW et al (1987) Oligoribonucleotide synthesis using T7 RNA polymerase and synthetic DNA templates. Nucleic Acids Res 15:8783–8798
Kallen KJ, Theß A (2014) A development that may evolve into a revolution in medicine: mRNA as the basis for novel, nucleotide-based vaccines and drugs. Ther Adv Vaccines 1:10–31
Ponchon L, Dardel F (2007) Recombinant RNA technology: the tRNA scaffold. Nat Methods 4:571–576
Nelissen FH, Leunissen EH, van de Laar L et al (2012) Fast production of homogeneous recombinant RNA—towards large-scale production of RNA. Nucleic Acids Res 40:e102
Ozsolak F, Platt AR, Jones DR et al (2009) Direct RNA sequencing. Nature 461:814–818
EDQM (2015) European Pharmacopoeia Online. http://online.pheur.org/EN/entry.htm. Accessed 20 Sep 2015
ICH (2003) Stability testing of new drug substances and products Q1A(R2). http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q1A_R2/Step4/Q1A_R2__Guideline.pdf. Accessed 7 Aug 2015
ICH (2009) Pharmaceutical development Q8(R2). http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q8_R1/Step4/Q8_R2_Guideline.pdf. Accessed 7 Aug 2015
European Commission (2008) EU guidelines to good manufacturing practice - medicinal products for human and veterinary use - Annex 1 Manufacture of Sterile Medicinal Products. http://ec.europa.eu/health/files/eudralex/vol-4/2008_11_25_gmp-an1_en.pdf. Accessed 4 Sep 2015
ICH (1999) Test procedures and acceptance criteria for new drug substances and new drug products: chemical substances Q6A. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q6A/Step4/Q6Astep4.pdf. Accessed 7 Aug 2015
ICH (1999) Test procedures and acceptance criteria for biotechnological/biological products. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q6B/Step4/Q6B_Guideline.pdf. Accessed 7 Aug 2015
Maxima Medical Center (2015) IMPD. http://www.mmc.nl/media/portal/mmc_documenten/impd. Accessed 7 Aug 2015
WHO (1997) Weekly Epidemiological Record No. 20. http://www.who.int/docstore/wer/pdf/1997/wer7220.pdf. Accessed 4 Sep 2015
Scheel B, Teufel R, Probst J et al (2005) Toll-like receptor-dependent activation of several human blood cell types by protamine-condensed mRNA. Eur J Immunol 35:1557–1566
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2017 Springer Science+Business Media New York
About this protocol
Cite this protocol
Schmid, A. (2017). Considerations for Producing mRNA Vaccines for Clinical Trials. In: Kramps, T., Elbers, K. (eds) RNA Vaccines. Methods in Molecular Biology, vol 1499. Humana Press, New York, NY. https://doi.org/10.1007/978-1-4939-6481-9_15
Download citation
DOI: https://doi.org/10.1007/978-1-4939-6481-9_15
Published:
Publisher Name: Humana Press, New York, NY
Print ISBN: 978-1-4939-6479-6
Online ISBN: 978-1-4939-6481-9
eBook Packages: Springer Protocols