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.