It is our policy to deliver safe products while meeting all applicable requirements.
Quality Statement
At BioStem Life Sciences, quality is essential to us because we value our customers' reputations and, above all else, their patients' safety. In our AATB® accredited, FDA registered, cGMP compliant lab, we strive to provide products and services which not only meet but exceed, Current Good Tissue Practice requirements.
Tissue Regulation
The products offered by BioStem Technologies™ include RHEO™, OROPRO™, AEON™, VENDAJE™, VENDAJE™ AC and VENDAJE™ OPTIC are perinatal tissue-derived allografts. They are designated as Human Cell, Tissue, and Cellular and Tissue-Based Products (HCT/P) by the U.S. Food and Drug Administration (FDA), are minimally manipulated, and are produced in accordance with the FDA regulations for Good Tissue Practices (21 CFR 1270, 1271).
Tissue Recovery and Processing
Microbiologic cultures are taken from each tissue
To maintain biological integrity, we process all tissue by using aseptic techniques in ISO 5 environments
Selected tissues are terminally sterilized by electron beam radiation
All tissues undergo multiple, separate quality assurance checks prior to release to ensure upmost quality and safety
Traceability is maintained for all tissues from recovery through testing, processing, packaging, and distribution
Donor Screening
Donor eligibility is based on screening and testing donors for relevant communicable diseases or disease agents (RCDADs). These tests must indicate that the donor is free from risk factors for, or clinical evidence of, infection due to RCDADs and is free from communicable disease risks.
Human immunodeficiency virus, types 1 and 2 (HIV-1/2)
Hepatitis B virus (HBV)
Hepatitis C virus (HCV)
Human transmissible spongiform encephalopathy (hTSE), including Creutzfeldt-Jakob disease (CJD)
Treponema pallidum (agent that causes syphilis)
Vaccinia
Sepsis
West Nile virus (WNV)
Zika virus (ZIKV)
Chlamydia trachomatis (CT)
Neisseria gonorrhea (NG)
Human T-lymphotropic virus, type I and type II (HTLV-I/II)
American Association of Tissue Banks (AATB®)
The American Association of Tissue Banks is the organization that sets standards, inspects facilities, and accredits tissue banks in North America. AATB trains and certifies tissue banking specialists. In crafting new federal regulations for tissue banking, the FDA has relied heavily on the expertise of the AATB.
