According to UK-based Asymptote, most cell and gene therapy makers thaw products through a manual process using a water bath but such methods are unreliable and place the end product at risk.
“Since thawing typically occurs at a very late stage in manufacturing, it is one of the most expensive places for a failure to occur,” CEO John Morris told Biopharma-Reporter.
“Although a water bath might be a cheaper initial purchase, the real cost for cell therapy manufacturers comes if the cells they have invested so much in producing, die as a result of a poorly controlled thawing process.”
As an alternative, the firm has launched the CellSeal automated thawing system, co-developed with Cook Regentec - a bioprocessing services company spunout of medical device maker Cook Medical.
The technology works through dry conduction and the whole thawing process can be programmed and controlled to avoid the uncontrolled and subjective issues associated with water baths.
“Thaw time depends on a number of factors like load temperature and the insulating effect of any labels on the vial,” Morris said. “The unit automatically compensates for these effects and ejects the vial when the exact thaw end point is reached.”
Furthermore, Morris told us demand for such a platform will only increase as more cell therapy manufacturers prepare to scale up their operations.
“As manufacturing scales across multiple sites and volumes increase, the need for a controlled, repeatable and easy to audit thawing process only becomes more important.”
While Morris said the CellSeal unit “is unique in the level of customization it provides when defining a thawing profile,” it is not the only alternative to water baths available to cell and gene therapy manufacturers.
In fact, thawing is a hot topic – pardon the pun - for cell therapy developers as personalised cell therapies are even generally more sensitive to temperature changes than other biopharmaceutical products.
Biocision, for example, expanded its cell thawing platform earlier this year to accommodate larger vial sizes, while other firms including Sartorius are looking into developing technologies to avoid potential problems during freezing and thawing operations.