To continue reading this article, sign up for FREE to
Membership is FREE
and provides you with
instant access
to email newsletters, digital publications, our full content catalogue & more...
American CryoStem Opens Stem Cell Processing and Storage Laboratory
American CryoStem Corporation has announced the Opening of our FDA registered tissue processing facility, located in Mount Laurel NJ. To date, the laboratory has processed in excess of 100 adipose tissue samples for long term storage of the adipose derived stem cells and regenerative cells.
American CryoStem's laboratory provides the highest quality tissue processing and storage services, operating in conformity with the PHS Act, current FDA regulations and guidance including current Good Manufacturing Practice (cGMP) and current Good Tissue Practice (cGTP).
In preparation for a timely submission for accreditation, we have implemented the additional guidance and methodologies of the American Association of Tissue Banks, The American Association of Blood Banks, and FACT-JACIE.
Our proprietary processing and internal controls assure our clients the highest quality services available which include: 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.
Anthony Dudzinski, Chief Operating Officer, stated, "We are pleased and excited about the completion of our laboratory and the introduction of our services to the market. We believe that our internal standards exceed current regulatory protocol. Our goal is to set the standard for the industry for the aseptic processing of adipose tissue and provide the highest 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."
American CryoStem has developed collaborative relationships with cosmetic, plastic, and orthopedic surgeons, as well as leading scientists in the field of regenerative medicine.
These collaborations will help accelerate usage of individual stored client samples in the fields of: cosmetic and plastic surgery (fat transplantation, natural breast reconstruction and enhancement, surgical scar healing); orthopedics (bone, muscle, and joint repair); and cardiology (heart, artery and vein repair).
