BIOTECHNOLOGY
The Xvivo system achieves complete closure, complete avoidance of air
and virtually no limits or constraints up-front or over time
systems (SUS), which have exploded in use. Keeping cells aseptic inside a pre-sterilised bag, bag/tube assembly or cassette is easy. Tere is less cleaning and virtually no biocide needed. Add to that the productive functionality of their associated mechanical devices, including and up to full automation, and it explains why these closed SUS devices are a dominant trend in modernisation. Some are uni-function SUS devices, designed for one step in production (e.g. cell separation). Some are multi-function SUS devices that do several steps (e.g. cell washing and dilution). Some actually do all the steps in production, and are fully automated (toti-function SUS devices). One of the most commercially successful is toti-function SUS devices designed for automated production of CAR-T cell cancer therapies. Although limited to one specific process, these are truly modern marvels. However, they don’t necessarily
produce the best or most cells. Recent comparability studies from the NIH show surprising results. Although the exposure to air is assumed to be minimal, it is not clear how well exposures to suboptimal transients of the critical process parameters temperature, CO2 O2
are avoided. Other variables inherent to each fixed SUS platform might also be
suboptimal and significantly influence the final cell product.
“Tis is the challenge with standardised
live cell process automation. Whether it is one step, or a few steps, or all the steps in production, an automated process that doesn’t degrade one kind of cell may degrade others,” explains Yerden. “Automating too early in development is a risk. Only clinical trials can tell if the cell product works. Developers need flexibility
until clinical trials prove successful, and canned automation is not usually flexible. “In development, only comparability studies can tell if a process change, such as automation, improves or hurts product quality. Tus uni-function SUS devices and multi-function SUS devices impose less risk because they do not automate the entire process, but then upstream and downstream steps may still be left exposed to air,” adds Yerden.
and Instead of air inside, it is filled with a mix of gases from tanks
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