In the industrialization of mRNA vaccines and therapeutics, storage and transportation have always been a critical bottleneck. Conventional mRNA‑LNP formulations require ultra‑low temperature storage at ‑20°C or even ‑80°C, which severely limits their global accessibility.

Lyophilization offers a solution to this challenge. By removing moisture from the formulation through vacuum freeze‑drying, mRNA‑LNPs can achieve long‑term stability under standard refrigerated conditions (2–8°C), eliminating the need for ultra‑cold logistics. This removes a major barrier to the widespread deployment of mRNA vaccines and therapeutics.

As an mRNA CRDMO centered on LNP delivery technology, Enorna has built end‑to‑end capabilities spanning plasmid, mRNA, and LNP/tLNP manufacturing. Building on this foundation, we are proud to launch our research‑grade LNP lyophilization service. Together with our established GMP‑grade lyophilization platform, we cover the full development lifecycle—from research‑grade sample preparation and process development to GMP‑scale manufacturing—enabling a true one‑stop CRDMO delivery from sequence design to lyophilized drug product. Our comprehensive technical support empowers partners at every stage of mRNA vaccine and therapeutic development and industrialization.

Part 1 Full-Scope Lyophilization Services | From R&D to Commercial Manufacturing

01 Research-Grade Lyophilization Service | Flexible Throughput, 7-Business-Day Rapid Delivery

• Flexible scale: 20–300 vials per batch, matching early-stage small-batch requirements

• Proven processes: Lyophilization validated for SM102 and other classical lipid formulations

• Process development: Supports rapid development and validation for novel lipid formulations

• Quality assurance: Full-process physicochemical data monitoring

• Rapid turnaround: Fastest delivery in as few as 7 business days (including preparation and testing)

• Cost-effective: Research-grade small-batch cost control

Applications: Candidate formulation screening, lyophilization protectant optimization, small-batch toxicology sample preparation, process feasibility studies.

02 GMP‑Grade Lyophilization Manufacturing | Fully Closed Aseptic Integration, Up to 6,400 Vials per Batch

• Fully automated, integrated line covering filling, stoppering, lyophilization, and crimping in a seamless sequence, with filling accuracy up to ±1%.

• Entire process requires no manual transfer, eliminating cross‑contamination risks

• Equipped with SIP (steam‑in‑place) and CIP (clean‑in‑place) systems for compliant and controlled equipment operation

• Proven processes established for classical lipid formulations including MC3, ALC 0315, SM 102, and others

• End‑to‑end quality control ensure batch to batch stability and consistency

Applications: Process scale‑up confirmation, toxicology batches, engineering batches, clinical batches, and commercial manufacturing.

Part 2 Full Chain CRO Services | From Sequence to Lyophilized Drug Product – One Step, End to End

Beyond our core lyophilization technology, Enorna offers a complete technical chain from sequence design to lyophilized drug product, providing integrated CRO services that reduce the costs of managing multiple vendors, ensure seamless process continuity, and maintain full data traceability.

Full-Service Coverage

• Sequence design and optimization: high expression, low immunogenicity, and stable structure

• Plasmid construction and preparation: FTO-compliant backbone, optimized supercoiled ratio, and high linearization efficiency

• mRNA IVT and purification: high integrity, high yield, and low dsRNA

• LNP/tLNP formulation development: formulation screening, novel lipid process optimization, and scalable manufacturing

• Lyophilization services: research‑grade lyophilization preparation, lab‑scale process optimization, pilot‑scale manufacturing, and GMP manufacturing transfer

The mRNA field is entering a period of rapid growth. Stable LNP delivery technology, compliant process development, and efficient R&D models are key to program success. Enorna remains committed to driving mRNA vaccine and therapeutic development from discovery to industrialization, powered by our core LNP delivery expertise.

Part 3 New Service Launch

To better support industry R&D needs, Enorna now offers full‑chain mRNA‑LNP CRO services, covering:

• mRNA drug substance preparation

• LNP/tLNP drug product

• Lyophilization process development and manufacturing

• NanoFCM analytical services

• mRNA Catalog products

These services support a broad range of research applications, including early‑stage feasibility studies, animal studies, and toxicology research.

For more information on our full‑chain CRO services, please reach out. Our team is ready to provide custom technical recommendations and flexible partnership options to meet your specific needs.