TISSUE ENGINEERING

Allograft tissue engineering Process

Pre Screening & Testing
In accordance with the legal requirements of the MFDS (Korea Food and Drug Administration) and the AATB (American Society of Tissue Banks) standards, we assessed donor suitability, which included serum and microbiological tests on the raw materials used in the processing of human tissue grafts to ensure (or guarantee) the safety of their use.
Serum Test Items
Hepatitis B, hepatitis C, AIDS, syphilis
Fungal Culture Test Items
Aerobic bacteria, anaerobic bacteria, fungi
Test
Antibody to the Human Immunodeficiency virus, type 1 and type 2(anti-HIV-1/2)
Nucleic acid test(NAT) for HIV-1(HIV-1 NAT)
Antibody to the Hepatitis C virus(anti-HCV)
Nucleic acid test(NAT) for HCV(HCV NAT)
 
Nucleic acid test(NAT) for HCV(HCV NAT)
Antibody to the Hepatitis B core antigen(anti-HBc)
Nucleic acid test(NAT) for HBV(HBV NAT)
RPR(or STS or VDRL) for Syphilis
AlloClean® : allograft tissue engineering
As a unique technology of L&C BIO that processes the raw materials of safe human tissues selected through a pre-screening and testing process, its chemical and sterilization processes are devised to meet the feature of each tissue so that it can effectively and safely remove unnecessary substances (foreign matter, microorganisms). Based on the AlloClean process, we have been safely processing human tissue grafts for tissue reconstruction and the survival and treatment of patients afflicted with various diseases.
Post Processing Testing
We evaluated the quality and safety of the end product by inspecting the packing state and the aseptic state of the processed tissue graft material.
Sampled for final microbial testing using swab cultures
Evaluated to a specification to ensure graft acceptability
Packaged in a sealed, sterile pouch
Labeled with: donor, tissue, product IDs, size, description, expiration date and storage instructions
AlloClean® Process

STERILIZATION

Learn more about our sterilization
The E-beam sterilization does not cause the destruction of collagen structure.
Preservation of collagen structure facilitates the influx of cells and angiogenesis after transplantation.
E-beam
MegaDerm®, MegaFill®
Gamma ray
MegaBone®, MegaCartilage®, MegaTendon®, MegaSheet®, MegaAmnion®
Superior retention
E-Beam sterilization induces adequate cross-linking of collagen for long term durability.