Your application Safe freezing and storage of viral vectors

Viral vectors are indispensable tools in modern cell and gene therapy. As carriers of genetic information, they enable the targeted modification of cells - for example in CAR-T cell therapies or in gene therapy with AAVs and lentiviruses. Due to their biological nature, viral vectors are extremely temperature-sensitive and susceptible to physical stress.

Why freezing and storage are crucial

The integrity and infectivity of viral vectors can only be maintained if they are frozen and stored under strictly controlled conditions. An uncontrolled freezing process can cause aggregation, structural changes or a reduction in biological activity - with a direct impact on the efficacy and safety of the final product.</p

A controlled freezing process for viral vectors is a central
building block for the quality and safety of modern cell and
gene therapeutics. To ensure that the sensitive particles retain their structure and
biological function throughout the entire manufacturing and delivery process, the freezing process must be precisely defined and reproducible at all times. Even the smallest deviations in the cooling rate
or target temperature can lead to damage to the viral envelope or to the
loss of infectivity - with potentially serious
effects on the efficacy of the end product.
The ability to process a wide range of container formats is just as crucial. In
clinical development, vials (individual containers) are usually used,
while bags or bulk containers are needed on an industrial scale in order to handle larger batches efficiently. The
freezing process must therefore be flexibly adaptable and compatible with all common
primary packaging materials without
impairing their material properties.

Another critical aspect is seamless process documentation. Only if all relevant parameters - such as temperature curves, holding times or batch labelling - are recorded and stored in a traceable manner can regulatory safe production in accordance with GMP requirements be guaranteed. This not only forms the basis for audits and authorisation procedures, but also for internal quality assurance.


In addition, the freezing process must be able to be seamlessly integrated into existing production processes. This applies to both spatial and temporal interfaces - from the upstream process to aseptic filling and long-term cryogenic storage. Ideally, the technology used is modularly scalable and can be adapted to new production stages or target quantities with minimal validation effort.


Only if all these requirements are met - precise temperature control, container compatibility, GMP-compliant process control and complete integration - can the stability, efficacy and safety of viral vectors be guaranteed in the long term. This is essential for the success of modern gene therapies and an indispensable quality feature along the entire supply chain.

Our freezing solutions enable a controlled cooling process down to below -80 °C and are tailored to the special requirements of viral vectors. Thanks to precise temperature control, flexible process adaptation and GMP-compliant integration, we offer a reliable basis for your production - even for demanding therapies and complex supply chains.

Ensure maximum process reliability for your viral vectors - with customisable freezing solutions from Refolution.

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Cornelia Schröder
Cornelia Schröder
Assistant to the management