mRNA is known as the "master key" to unlocking various diseases. Compared with DNA medicines, mRNA is translated within the cell and does not enter the nucleus, eliminating the possibility of integrating into the host genome. Furthermore, many proteins that are difficult to treat in vitro can be translated and produced in vivo via mRNA, released into the extracellular space, targeted at receptors, or circulated. mRNA medications simplify complex treatments and potentially make tumor vaccinations, protein replacement therapies, and other therapies more feasible. Therefore, mRNA can be converted into vaccines or medications and is widely utilized in infectious disease prevention, tumor immunotherapy, protein replacement therapy, and gene editing to cure hereditary illnesses.
However, all genetic sequences are susceptible to random mutation, and in vitro synthesized mRNA products are unstable. As a result, stringent QC should be carried out to assure product safety, identification, quality, purity, and so on. As a leading service provider in mRNA development, Creative Biolabs provides mRNA product QC services to support your drug development.
Creative Biolabs offers a wide range of mRNA QC services, including mRNA identification (such as sequence length, sequence integrity, accuracy, and so on), purity, impurity (such as residual protease, DNA template residue, organic solvent residue, and so on), safety, functionality, and LNP Indicators (packaging efficiency, particle size, PDI, Zeta potential). Table 1 displays the specific QC components. Creative Biolabs' mRNA includes conventional QC services by default after production, with upgraded QC available based on unique project requirements.
Tab 1: Quality Control Methods
| mRNA Quality Control | |||||
|---|---|---|---|---|---|
| QC | Items | Methods | Specification |
RUO Default |
RUO Upgrade |
| Identity | Appearance | Visual Inspect | Clear | √ | |
| Sequence | Sanger, NGS | Expected | √ | ||
| Length | Gel, CGE | Target ±30% | √ | ||
| Capping efficiency | LC-MS | ≥90% | √ | ||
| Poly(A) Length | LC-MS | Target ±30% | √ | ||
| Purity | Integrity | Gel, CGE | Expected | √ | |
| A260/280 | UV Spec | 1.70~2.30 | √ | ||
| Impurity | dsDNA | Slot-blot | ≤0.1% | √ | |
| Plasmid DNA | qPCR | ≤0.05% | √ | ||
| Protein | Nano Orange | ≤1% | √ | ||
| Safety | Endotoxin | KCA | ≤10EU/mg | √ | |
| Sterility | Bioburden | No Growth after 48hrs | √ | ||
| Mycoplasma | qPCR | No mycoplasma DNA | √ | ||
| Functionality | Transcription | qPCR | expected | √ | |
| Translation | Western blot | expected | √ | ||
| LNP | Packaging efficiency | Ribo Green | ≥95% | √ | |
| Particle size, PDI | Dynamic light scattering | POI±20nm, PDI<0.28 | √ | ||
| Zeta Potential | Zetasizer | ±15 mV | √ | ||
*RUO: Research use only
Creative Biolabs also provides mRNA QC services separately. You are welcome to submit us mRNA samples for quality control, and we will do an accurate QC analysis on your IVT mRNA samples to confirm the purity of your mRNA. Please contact us if you have any unique needs, and our technical support team will be happy to help.
