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About Us

RNA technology

Own patented liquid dosage form heat stable delivery system, RTU LNP technology, has realized the stability verification of 2-8 ℃ storage for more than 18 months

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Non-self-replicating mRNA stock solution

Own patented liquid dosage form heat stable delivery system, RTU LNP technology, has realized the stability verification of 2-8 ℃ storage for more than 18 months

Test Results Customized Demand Range

The RNA Platform Case

Traditional non-self-made replication RNA (we ourselves are enzymatic, enzymatic to 100%)

> The capping rate is stable over 98%;

> mRNA purity over 90%;

> Maintaining good batch-to-batch consistency

Non-self-replicating mRNA stock mRNA purity, capping rate, Poly(A) tail length distribution

Test Items	Test Methods
Appearance	Visual inspection
pH	Potentiometry
mRNA concentration	UV/Ribogreen
5' capping efficiency	LC-MS
Poly A tail distribution	LC-MS/CE
mRNA integrity	CE/HPLC/Agarose gel
Sequencing	Sanger
dsRNA residues	ELISA/Dot-blot
IVTase residue (total protein)	ELISA/NanoOrange
DNA template residue detection	ddPCR
Sterility testing	Pharmacopeial methods
Endotoxin Testing	Pharmacopeial methods

Non-self-replicating mRNA preparations

Own patented liquid dosage form heat stable delivery system, RTU LNP technology, has realized the stability verification of 2-8 ℃ storage for more than 18 months

Test Results Customized Demand Range

Test item	Test method
Appearance	Visual inspection
pH	Potentiometric method
Load	Weight
Osmolality	Freezing point method
Particle Size	Dynamic Light Scattering (DLS)
PDI	Dynamic Light Scattering (DLS)
Zeta Potential Detection	Phase Analytical Light Scattering (PALS)
mRNA concentration	HPLC/Ribogreen
mRNA-LNP lipid concentration	UPLC-UV/UPLC-ELSD
Sequencing	Sanger
mRNA-LNP lipid identification	UPLC-ELSD
mRNA integrity	CE/HPLC/Agarose gel
Encapsulation rate	Ribogreen
Ethanol residue	GC
Sterility testing	Pharmacopeial methods
Endotoxin Detection	Pharmacopeial Methods
In vitro potency	FACS/ELISA

Service guarantee

Project Experience

1. Complete 1 phase 1/2 clinical drug supply, and obtain 4 FDA IND approvals and 2 CDE IND approvals in total
2. Cumulative completion of 40 Tox & GMP batches
3. Service customers covering institutions, Biotech and well-known pharmaceutical companies

intellectual property protection

1. A clear confidentiality agreement to protect the customer's intellectual property rights;
2. Improve the project management mechanism to reduce project risk;
3. Strict account three-level authority management to effectively guarantee equipment operation authority;
4. Stable electronic data storage media, to achieve rights management, effectively guarantee the security and integrity of the data life cycle;
5. Standard IT technology methods realize physical isolation between office network and production network, control of computer USB rights, management of employees' online behavior, and restriction of users' query, copy and export of customer information.

Quality Management

1. According to ICH guidelines and FDA, EMA, NMPA and other requirements, a perfect quality system conforming to GMP requirements has been established, and more than 350 existing SOP and batch production record documents have been controlled.
2. Established a sound supplier management system
3. The standard EMS monitoring system can monitor the stability of key parameters such as temperature, humidity and pressure difference in the production workshop, clean room or storage facilities in real time to ensure the stability and safety of the production environment.
4. Standard computerized validation and verification system