In 1961, Brenner et al discovered mRNA for the first time as an intermediate hereditary substance in the central dogma (from DNA, to RNA, to protein). In 1990, in vitro transcribed mRNAs were fully expressed by direct injection into mammalian cells, demonstrating successfully for the first time that mRNAs could be expressed in vivo and that mRNA-based vaccines could be developed.
Since then, structural pattern, editing, delivery, and other related technologies for mRNAs have advanced rapidly. And ex vivo mRNAs were first transfected into dendritic cells in 2002 in the clinical trial for stimulation of cytotoxic T-cells against cancer. In 2020, mRNA vaccines against coronavirus disease 2019 (COVID-19) were approved, which has further increased the interest and expectation in mRNA. Currently, mRNA-based vaccines and drugs are being actively investigated for the treatment of a variety of diseases, including infectious disease, cancer, and protein/enzyme deficiency.
In Vitro Synthesis of mRNA
5’ Cap Modification
PolyA Modification
Nucleotides Modification
mRNA Delivery System
mRNA Vaccines
mRNA Therapeutics
Others
mRNA Reagent
| mRNA CDMO Services
|
Grade | Deliverables | Specification | Applications |
non-GMP | Drug Substance, mRNA | 0.1~10 mg (mRNA) | Preclinical research such as cell transfection, Analytical method development, Pre-stability studies, Formulation development |
Drug Product, LNP-mRNA | |||
GMP, Sterility | Drug Substance, mRNA | 10 mg~70 g | Investigational new drug (IND),Clinical trial authorisation (CTA), Clinical trial supply, Biologic license application (BLA),Commercial supply |
Drug Product, LNP-mRNA | 5000 vials or pre-filled syringes/cartridges |