Development of mRNA manufacturing for vaccines and therapeutics: mRNA platform requirements and development of a scalable production process to support early phase clinical trials.
Whitley J, Zwolinski C, Denis C, Maughan M, Hayles L, Clarke D, Snare M, Liao H, Chiou S, Marmura T, Zoeller H, Hudson B, Peart J, Johnson M, Karlsson A, Wang Y, Nagle C, Harris C, Tonkin D, Fraser S, Capiz L, Zeno CL, Meli Y, Martik D, Ozaki DA, Caparoni A, Dickens JE, Weissman D, Saunders KO, Haynes BF, Sempowski GD, Denny TN, Johnson MR.
Whitley J, et al.
Transl Res. 2022 Apr;242:38-55. doi: 10.1016/j.trsl.2021.11.009. Epub 2021 Dec 4.
Transl Res. 2022.
PMID: 34871810
Free PMC article.
Review.
To date, production processes have either not been disclosed or are bench-scale in nature and cannot be readily adapted to clinical and commercial scale production. ...Finally, we discuss continued challenges in raw material identification, sourcing and supply, and the …
To date, production processes have either not been disclosed or are bench-scale in nature and cannot be readily adapted to clinical a …