Procurement and preparation of an amniotic membrane allograft have posed multiple challenges. Early traces of experiments and solutions date all the way back to the twentieth century.1 We have developed our own set of practices with minimal manipulation, called the AGNES proprietary technology, to develop a sterile human amnion chorion allograft for wound healing.
What Is Agnes Proprietary Processing Technology?
AGNES proprietary processing technology is a custom method to process our product, the AmchoPlast - an allograft prepared from donated placental tissue. The allograft is used for wound healing as placental tissue has wound-healing properties.2 Moreover, it can maintain the structural proteins, cytokines, and growth factors of the native extracellular matrix.3 These therapeutic properties are utilized thoroughly by minimally processing the human amnion chorion tissue to make an advanced wound care product that regulates inflammation and reduces scar tissue formation for patients.
If we are to understand the AGNES proprietary processing technology in simple terms, it is the preparation of the collected placental tissue sample via screening, washing, dehydration, and sterilization in our lab to make it suitable for grafting on the abrasion. Once processed through the AGNES proprietary processing technology, the AmchoPlast is cut into various different sizes and sterilized for packaging.
What Are The Steps Involved In The Agnes Process?
Here’s a detailed rundown of the steps involved in the AGNES proprietary processing technology.
The donated placental tissues are screened with utmost diligence to eliminate any chances of infectious agents. First, they need to fill up a questionnaire with accurate information. Second, once the sample is delivered to the lab, it is tested to check if it is free from any kind of microorganism. In addition, the maternal blood is checked for diseases like malaria, typhoid, syphilis, HIV, Hepatitis C, and many more. AGNES proprietary processing technology maintains high standards while screening meticulously for a wide array of parameters to ensure qualitative results.
After sending a small amount of sample for screening, the rest of the donated placental tissue is washed comprehensively. Initially, the AGNES process involves placing the sample in an antibiotic solution to eliminate the microorganisms. Then comes a round of chemical washing. This is done to remove the blood clots from the placental tissue. Such methodical decontamination is required to avoid even the slightest chance of the graft further infecting the wound.
The next step in the AGNES proprietary processing technology is drying the cleaned tissue sample. The dehydration makes for a beneficial step in this procedure as it enables terminal sterilization of the product.
After dehydration, the tissue sample is packed in a double-layer aluminium pouch and placed in a tertiary pack and sent for gamma sterilization. Gamma sterilization is successfully proven to be a better alternative to other techniques when it comes to tissue allografts.4 It is a simple, safe and energy-efficient sterilization process. Therefore, gamma radiation is commercially used to sanitize healthcare products.
Moreover, it has the capability to eliminate bacteria, viruses, and fungi from the sample without tampering with the biomechanical or structural properties of the tissue graft. Such sterilization reduces the risk of microbial disease transmission from the donor.
5. Testing And Release
Once sterilized, the product is tested as per predefined specifications. After extensive testing and upon qualification, the products are finally ready for dispatch.
Accreditation For LifeCell Lab For Tissue Processing
LifeCell upholds high standards for all its procedures and the same goes for our AGNES procedure. The method is in compliance with the regulations of the American Association of Tissue Banks (AATB), National Organ & Tissue Transplant Organization (NOTTO), World Health Organization (WHO), and the Good Manufacturing Practice (GMP) system. Such standardized processes improve our efficiency and help ensure greater safety and consistent performance while creating every product.
The human amnion chorion membrane has great potential for wound healing and care application in the clinical setting. It shows promising applications in acute and chronic ulcers, surgical wounds, traumatic wounds, and more. However, it is important that the tissue is procured and processed with minimal manipulation, utmost efficiency and standard practices. AGNES proprietary technology sets the path for processing our product AmchoPlast and helps us deliver the best output in terms of wound care.