Annual IBC Cell Therapy Bioprocessing meeting has finished this week in Arlington (Virginia). Today I’ll share some information, that I’ve learned from a session, dedicated to cell therapeutics biopreservation and loogistics.
At the beginning of the conference Lee Buckler (Cell Therapy Consulting Group) highlighted one of the future trends in cell therapy – we will see variety of cell delivery formats (likely not in LN2!). To his point, Aby Mathew (BioLife Solutions) called to think about cell storage and delivery format in broader term – “biopreservation“, rather then “cryopreservation”. Biopreservation includes ambient storage, hypothermic storage, cryopreservation, vitrification and anhydrobiosis (drying). Is era of cryo- LN2-free storage and delivery coming to cell therapy field? Well, at least hypothermic storage is expanding now (vitrification and anhydrobiosis are not yet validated for clinical use). For example, HypoThermosol – cryopreservation-free, cold chain supply solution – is being used in >130 clinical trials. It allows short-term cold storage for few days without significant drop in cell viability and functionality.
Mathew is known proponent of concept for assessment of delayed onset cell death (learn more from these videos), which shows difference between perceived viability and true viability. Even though true viability measurement (24h in culture after thaw) is more accurate assay for cellular products, we still cannot track cell viability in human body after infusion. In product and process development he recommended to use variety of methods to assess “cell health”, such as: mechanical (attachment), proliferation, engraftment, protein/ cytokine production, cytotoxicity… and try stay away of traditional “trypan blue” test.
Aby Mathew noticed that: “Billions spent annually on cold chain logistics of biologics, cells, organs”, only because we don’t know good practices and do a lot of errors. There is a Good Distribution Practices (GDP) in biologics logistics, that we can learn and follow. We can implement real-time monitoring of cell product shipping, instead of retrospective “failure analysis” (after product was destroyed). Even simple switching from home-made cryo- and bio- preservation solution to commercially available, will allow to drop a number of errors.
Another way to avoid errors in logistics and cold chain is standardization and development of new tools. This is a mission of relatively new company in the field – BioCision. The company is entering cell therapy with tools, enabling standardization of cold chain logistics – packing, shipping, clinical site handling. They presented the first case study in cell therapy, where LN2-free, controlled rate freezing container CoolCell was used for clinical trial by TxCell SA. Hazard-free (no alcohol as in Mr. Frosty or LN2 required) freezing process is significant step forward! BioCision also presented some new products: BioT Temperature Stability Systems.