Services
mRNA design → Manufacture → Deliver
Design
If both the mRNA and the protein possess long half-lives, this leads to sustained high levels of protein expression within the cell. The stability of mRNA ensures ample time for protein synthesis, whereas the long half-life of the protein guarantees that once synthesized, they will retain their activity for an extended period within the cell. Consequently, for proteins that require continuous and stable expression, design considerations should include enhancing both the half-life of the mRNA and the half-life of the protein. This dual strategy facilitates the maintenance of steady-state protein levels necessary for sustained cellular function.
Process development--three-level seed lot establishment
We provide three-level seed lot establishment services under GMP conditions, seed lot stability tests, and comprehensive strain analysis services. Our strains have high passaging stability, with a poly A tail recombination rate of less than 10% at high passage numbers.
Process Development-Plasmid Process Development
We have a stable and reliable fermentation and plasmid purification process with comprehensive process control, clear and traceable records. The DNA template product shows high purity (>90%), low recombination rate (<5%), low endotoxin (<0.1EU/μg). We can provide a full set of DNA template analysis services.
mRNA Process Development
Using high-fidelity T7 polymerase, we offer a stable and reliable mRNA synthesis and purification process, with comprehensive process control, clear and traceable records. Our mRNA products show high purity (>90%), high capping efficiency (>90%), and low double-stranded residue levels (<1μg/mg). We can provide a complete set of mRNA analysis services.
Manufacture
CMC is an important part of new drug registration, mainly involving four modules in mRNA therapeutics areas: seed lot establishment, plasmid preparation, mRNA synthesis, and LNP preparation and filling. Among them, product quality, impurity control, process control, and process stability are all key points for mRNA therapeutics development.
In Vitro Transcription mRNA
Messenger RNA (mRNA)-based drugs innovation have been widely proven as a promising treatment strategy in immune therapeutics. Our mRNA one-stop service obtained synthesis, sequencing, IVT and evaluation. The fast, efficient and comprehensive mRNA services will help your drug innovation, overcome experiment challenges and time saving in the competitive market environment.
Evaluation-In vitro activity verification of mRNA
Different CAP structures, UTR sequences, nucleotide modifications, and CDS sequences can all affect the expression level of mRNA. The transfection and expression efficiency of mRNA can be evaluated by detecting the expression or activity of the target protein using methods such as flow cytometry, western blot, and ELISA.
Delivery
Several lipids form lipid nanoparticles (LNP) carrying mRNA to targeted organelles or tissues, improving their in vivo transfection efficacy. Although mRNA therapeutics show high potency in many areas, challenges in specific-targeted delivery and poor physiochemical stability still impede their accessibility.
Equipment for mRNA-LNP preparations
Providing mRNA-LNP preparation equipment with full specification coverage to meet all requirements (from research to CMC production).
Lyophilization platform of Enobio
Enobio has repeatedly screened and optimized for every detail, and systematically summarized the experience of mRNA-LNP lyophilization.
Excellent stability of lyophilized samples
Comparison of the stability of lyophilized formulations under different storage conditions.
