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Experienced global provider of integrated CDMO services

Patented LNP delivery system with extended shelf-life and thermostability, proven in human clinical trials with IND approvals from NMPA and FDA.

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Integrated RNA drug development and manufacturing platform

Dedicated to providing convenient and reliable development and manufacturing services for RNA therapeutics and RNA vaccines.

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Dedicated to creating value for customers

Careful design, strict production, high efficiency and stability, dedicated service, and quality assurance.

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Dedicated to creating value for customers

Careful design, strict production, high efficiency and stability, dedicated service, and quality assurance.

Learn more

Dedicated to creating value for customers

Careful design, strict production, high efficiency and stability, dedicated service, and quality assurance.

Learn more

RNA Technology

Patented heat-stabilized delivery system for liquid dosage forms, RTU LNP technology, which achieves the stability verification of over 18 months of storage at 2-8℃.

Non-self-replicating linear mRNA

mRNA Covid Vaccine has been a great success, and safety and efficacy have been widely verified

Self-replicating RNA

Lower dose, longer expression time in vivo, can carry multiple protein sequences at the same time

Circular RNA

Robust CMC manufacturing process, rapid clinical translation

Innovation and internationalization

About Immorna

Immorna offers access to an integrated RNA drug development and production platform, dedicated to providing one-stop-shop, flexible and reliable development and manufacturing services for RNA therapeutics and RNA vaccines. Immorna's products have received multiple IND approvals from the FDA and NMPA and are being used in clinical trials both in the US and China. With the concept of "Collaboration Accelerates Innovation", we have already cooperated with CROs, research institutes, Biotech and other organizations.

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> Established

2021

> Technology Patents

16 + patents

> IIT drug supply

> Clinical Trials

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.

Experienced Experts

> 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.

Patented Technologies

> 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.

Manufacturing Facilities

> We have established our own large-scale state-of-the-art GMP pilot workshop with a batch freeze-dried powder production capacity of up to 4,000 units. Our full production cycle coverage allows us to undertake sample production, manufacturing, and testing releases for Pre-IND, IND, and early clinical stage trials. We have obtained IND approvals from the FDA and CDE for multiple product varieties and have successfully supplied them for clinical trials.

> Our C+A and B+A cleanroom areas are thoughtfully laid out with air purification systems and customized temperature and humidity control systems. Additionally, they are equipped with particle and microbiological monitoring systems for comprehensive environmental control.

> Immorna has a 25,000-square-meter GMP production workshop, and our in-progress capacity is set to reach an annual production capacity of 200 million units.

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