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About Us

CDMO Services

With a one-stop RNA drug discovery and manufacturing platform, Immorna is committed to providing convenient and reliable development and manufacturing services for RNA therapeutics and RNA vaccines. Immorna's products have received multiple IND approvals from NMPA and FDA, and are in clinical trials in China and the US. Immorna has a number of proprietary technology platforms, including RNA "dumbbell" structures that enable single-stranded multivalent design, clinically validated self-replicating vectors, unique patented multi-component targeted LNP design, stable lipid carrier process formulation, and domestic RTU vectors with long term thermal stability. Biopharmaceutical companies use Immorna as an important supplier and partner for RNA design and liposome encapsulation to complete the transition from early stage research to clinical trials.

Custom Services>

Immorna process development and production services

Sequence Design

> Non-replicating mRNA/self-replicating RNA/Circular RNA > Codon optimization > Elements Design > Nucleotide modification

Plasmid Preparation

> Plasmid Screening > Strain Screening > Seed bank construction > Seed bank validation > Plasmid Production

In vitro transcription of IVT

> Capping efficiency ≥98% > Single batch RNA yield up to gram level

RNA purification

> Purity ≥95% > DNA template residue ≤5ng/dose > Protein residue ≤1000 ng/dose

Vector Design

> Efficacy/safety/stability > Process Scalability

Encapsulation

> RNA encapsulation 99% > Lipid purity 98% > Thermal stability > Particle size 40- 120nm (on demand) > PDI less than 0.100

Filling delivery

> QC > QA > Formulation > 25,000 bottles in a single batch

Analytical Methods

> Development > Validation

Stability Studies

> Long-term Stability > Accelerated Stability > Forced Degradation Stability > Stability in Use > Transportation Stability

IND Filings

> NMPA > FDA > 3 pipeline FDA IND approved + 1 pipeline NMPA IND approved

Service Guarantee

Project Experience

> We have successfully completed Phase 1/2 clinical drug supply for 3 trials and obtained a total of 4 FDA IND approvals and 2 CDE IND approvals.

> We have accumulated experience in completing more than 40 Tox and GMP batches.

> Our clientele spans academic institutions, biotech companies, and renowned pharmaceutical enterprises.

Intellectual Property Protection

> We have clear confidentiality agreements in place to safeguard our clients' intellectual property.

> Our comprehensive project management mechanisms are designed to reduce project risks.

> A strict three-tiered account authorization system is enforced to effectively manage equipment operation permissions.

> We ensure stable electronic data storage media with robust permission management, ensuring the security and integrity of the data throughout its lifecycle.

> We employ standard IT techniques, including physical segregation of the office network from the production network, USB access control, employee internet usage management, and restrictions on user access to client information, preventing queries, copying, exporting, and similar actions.

Quality Management

> We have established a robust quality system in compliance with GMP requirements, following ICH guidelines, and meeting the expectations of regulatory bodies such as FDA, EMA, and NMPA. We maintain control over more than 350 existing SOPs and batch production record documents.

> We have implemented a comprehensive supplier management system.

> Our standard EMS monitoring system enables real-time tracking of the stability of key parameters like temperature, humidity, and pressure differentials within production areas, cleanrooms, or storage facilities. This ensures the stability and safety of our production environment.

> We adhere to a standardized computerized confirmation and validation system.

Original liquid quality control

Stability of 6 months at -60℃ storage condition

Non-self-replicating mRNA stock solutions Self-replicating RNA stock solution Customized Demand Range

RNA Platform Examples

Traditional non-self-replicating RNA

> Stable cap rate over 98%;

> mRNA purity exceeds 90%;

> maintained good batch-to-batch consistency

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

Examples of RNA platforms

Self-replicating RNA synthesis platform

> Capping rate ≥90%

> mRNA purity ≥70%

Self-replicating RNA stock solution mRNA purity, capping rate, Poly(A) tail length distribution

Self-replicating RNA 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

Formulation Quality Control

Patented heat-stabilized delivery system for liquid dosage forms, RTU LNP technology, achieving stability verification of over 18 months of storage at 2-8°C.

Non-self-replicating mRNA preparations Self-replicating RNA preparations Customized Demand Range

Non-self-replicating mRNA formulation PDI, particle size

Non-replicating mRNA formulation encapsulation rate, mRNA purity

Self-replicating mRNA preparation PDI, particle size

Self-replicating mRNA preparation wrapping rate, mRNA purity

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