Human Serum

Access Biologicals offers a variety of human serum products manufactured under cGMP.
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Human Serum Products

Human Male AB Serum:

Our human serum is collected from donors meeting the health requirements established by 21CFR 640, subpart G using plasmapheresis. The plasma is collected at FDA licensed facilities in the US. These individual units are converted to serum from plasma using our proprietary process under cGMP at an ISO certified manufacturing facility. They are pooled, filtered, bottled and USP tested for mycoplasma and endotoxin. Each individual unit is tested and found negative for all required viral markers using FDA-approved methods as well as HTLV I/II and West Nile Virus.

  • Human Male AB Serum is the serum of choice for work involving human cells: Tissue Engineering, Transplantation of T Cells & Cell therapy applications
  • Access Cell Culture is the only company to directly collect  human AB serum at FDA-licensed facilities located in the US
  • The material is processed under cGMP in an FDA registered, ISO certified facility
  • Donors sign consents and are screened for compliance to 21CFR 640
  • Full FDA viral testing conducted
  • Additional viral testing added per Access Cell Culture internal specifications
  • Additional testing available upon request
  • .1 micron filtered
  • Lot sizes from 1L to 400L available
  • Available with Bovine Thrombin or Human Thrombin  

Human Male AB: Off-the Clot Serum

  • Our Off-the-Clot AB serum is collected from healthy male donors in the United States at FDA licensed facilities. It has been allowed to coagulate naturally and contains no anticoagulants or preservatives. They are pooled and processed under cGMP.
  • Donors sign consents and are screened for compliance applicable to 21 CFR
  • Full FDA viral testing conducted
  • Additional viral testing added per Access Cell Culture internal specifications
  • Additional testing available upon request
  • Lot sizes from 1L to 50L available

HumaCell:

is a non-AB human serum meant for use on human cells where FBS is being used. It is 100% mixed gender, mixed blood type human serum manufactured using our proprietary process under cGMP.
  • HumaCell is suitable for use in regenerative medicine, cryopreservation media and therapeutic applications
  • Raw material is collected at FDA-licensed facilities located in the US
  • The material is processed under cGMP in an FDA registered, ISO certified facility
  • Donors sign consents and are screened for compliance to 21CFR 640
  • Full FDA viral testing conducted
  • Additional viral testing added per Access Cell Culture internal specifications
  • .1 micron filtered
  • Lot sizes from 1L to 400L available
  • Available with Bovine Thrombin or Human Thrombin

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