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news.American CryoStem has opened FDA registered stem cell processing facility and storage laboratory in Mount Laurel, New Jersey, US.
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American CryoStem’s laboratory provides tissue processing and storage services which comply with the PHS Act, current FDA regulations and guidance including current Good Manufacturing Practice (cGMP) and current Good Tissue Practice (cGTP).
In addition the company has implemented the guidance and methodologies of the American Association of Tissue Banks, The American Association of Blood Banks, and FACT-JACIE.
American CryoStem also provides perpetual chain of custody monitoring, multiple in-process sterility and viability tests, recovery and bio-generation tests to measure the expansion and differentiation abilities of each stored client sample.
American CryoStem COO Anthony Dudzinski said the company hopes to set benchmarks for the industry for the aseptic processing of adipose tissue and provide quality cellular samples.
"Our proprietary cGMP/cGTP processing consistently yields large volumes of uncontaminated regenerative cells that can be retrieved by our clients at any time," Dudzinski added.