ANALYTICAL & LABORATORY EQUIPMENT
The test bed is the only available lab space where an entire cell production process can be put inside an enclosed system for testing
“Te Test Bed is essentially a collection of state-of-the-art technologies that assist companies that want to do prototyping and advance their manufacturing process for a regenmed technology or product,” explains Josh Hunsberger, PhD, and chief technology officer of ReMDO. “BioSpherix is the cornerstone technology. Tey have built a cytocentric testing facility, an end-to-end manufacturing system that is the only place in the word companies can come in and have access to the equipment.” Te Xvivo system is flexible enough to accommodate almost any manufacturing process, “so companies can come in from around the world and test it out and see how well their manufacturing processes perform,” adds Hunsberger. Te BioSpherix system takes
conventional practices, in place for half a century, and turns them around, putting the focus on optimised cell generation. Because it is a closed system, it can be operated in ISO-8 environment and does
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not require a Class A or B cleanroom environment.
Tis stands in contrast to current
Good Manufacturing Practices (GMP), which are almost entirely based on using cleanrooms. However, for best viability and potency, cells need full-time optimisation of all critical parameters or suffer from degradation of genotypic and phenotypic integrity, as well as variability in cell populations. Even with a high level of control, environmental variations occur in cleanrooms during processing. Cleanrooms may have controls over temperature, dust, and particulates, but not over the level of O2
in the air. When the product is put in and taken out of a safety hood. Te samples can be exposed to open air, compromising the quality control. According to Green, “Te Xvivo system
or CO2
provided a real cost-efficient alternative to a cleanroom environment, particularly at the testing and product development level.” Atala agrees. “Cost is extremely important because these technologies can get very
expensive to develop. Between the media that is used to grow the cells, the labour involved, the maintenance of the facility, the process development, the quality assurance, and quality control features – all these can get very expensive. By having a unit that is compact, self-contained, with all the air quality and specifications needed that are required by the FDA, you can decrease the overall costs.” “Lower cost of production leads to
lower cost of the product, which means that more patients will be able to benefit from these technologies,” he adds. Atala says Te RegeneratOR Test Bed
will strengthen the already extensive “ecosystem” of resources to advance regenerative medicine technologies in the region. “Te RegenMed Hub is an intersection of businesses, manufacturing companies, societies, and foundations that support the advancement of regenerative medicine, with the ultimate goal of accelerating these technologies to patients.”
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