Your application Safe freezing and storage of mRNA and API

mRNA (messenger ribonucleic acid) is the blueprint for the production of specific proteins in cells and forms the basis of modern, highly effective vaccines. APIs (Active Pharmaceutical Ingredients) are the pharmacologically active substances which, in combination with mRNA, can specifically trigger an immune response in the body. Both substance classes are extremely sensitive to temperature fluctuations and mechanical influences.
In order to maintain quality, stability and efficacy throughout the entire value chain, precisely controlled temperature management during freezing and storage is essential. Especially in the large-scale production and intermediate storage of clinical batches, processes must be validatable, reproducible and GMP-compliant - this is the only way to guarantee therapeutic safety.

Controlled cryopreservation for maximum stability of sensitive RNA active ingredients

mRNA (messenger RNA) is a single-stranded molecule that serves as a temporary genetic guide for the production of an antigen - for example in vaccines against SARS-CoV-2. In modern pharmaceuticals, mRNA is often embedded in formulations with lipid nanoparticles (LNPs) to make it more stable, bioavailable and cell-permeable.
In pharmaceutical manufacturing, the term API (Active Pharmaceutical Ingredient) is used either for the unformulated mRNA (drug substance) or for the formulated, ready-to-use LNP mRNA (drug product) - depending on the regulatory dossier. Both variants are particularly sensitive to temperature changes, mechanical stress and enzymatic degradation.

Both the unformulated mRNA and the formulated mRNA in LNPs must be frozen and stored under controlled conditions to maintain their integrity and efficacy.

Uncontrolled freezing - e.g. by direct storage at -80 °C without controlled cooling - can lead to fragmentation of the RNA,

destruction or segregation of the lipid nanoparticles,

as well as aggregate formation or loss of active substance.

This has a direct impact on the therapeutic quality of the product - and in the worst case can lead to rejection of the batch.

A precisely controlled freezing profile with a defined cooling rate (e.g. -1 °C/min) enables uniform ice nucleation and prevents the formation of harmful micro ice crystals. This protects the physical stability of RNA and nanoparticles.

Such a process is reproducible, process-safe and, above all, GMP-validatable - a key aspect in the regulatory release of modern biopharmaceuticals.

In order for mRNA active ingredients to be frozen and stored safely, the technology used should enable reproducible, precisely controllable temperature control, be suitable for different container formats such as vials, bags or bulk systems, offer validated, documentable process control and be able to be integrated into existing manufacturing processes in a GMP-compliant manner.

This is the only way to ensure reliable and safe intermediate storage or long-term storage - both for clinical batches and for large-volume series production.

Most mRNA-based APIs today are stored deep-frozen at -20 °C to -80 °C. Optimised formulations can even be stored in the refrigerator range (2-8 °C) for limited periods of time.

A standardised freezing procedure not only protects quality during storage, but also during thawing, transport and multiple withdrawals.

For long-term storage, retention samples or global distribution, a stable frozen product is of crucial importance. This is the only way to ensure that the end product has the same efficacy at the point of treatment as intended in the manufacturing process.

The freezing and storage of mRNA-containing drugs is not a purely technical process step, but a key quality factor.
It is decisive for the stability, safety and regulatory approvability of the end product. Only with a controlled, validated freezing and storage concept can modern RNA-based medicinal products be manufactured reliably and scalably - from clinical development to commercial production.

Refolution supports you with customised solutions for GMP-compliant freezing processes, precise temperature control and flexible system integration. Whether for vials, bags or bulk - our technologies guarantee maximum reproducibility and process reliability with minimum risk.
Talk to us about your project - we will support you from process development to the implementation of a validated freezing and storage concept for mRNA and API.

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