Surgenex® is an industry leading contract research and manufacturing organization specializing in human cellular and tissue-based products.
Surgenex®is an industry leading biotechnology firm focused on the development and commercialization of placental tissue and musculoskeletal based implants meeting stringent quality and safety standards.
We offer a full suite of processing capabilities to supply traditional birth tissue and musculoskeletal allografts through customized, innovative implants.
Our dedicated team of professionals focuses on exceeding expectations by combining in-depth industry experience and a robust quality system to deliver exceptional quality, best in class customer service, and a commitment to on time delivery.
The Excellion® processing philosophy is centered on tightly controlled procedures focused on:
Independent, contracted tissue recovery agencies follow strict protocols in accordance with FDA regulations and AATB standards. Serological and microbiological testing is performed at an independent, CLIA certified, FDA registered laboratory against standards that exceed the requirements of the FDA and AATB. Final donor eligibility is determined by a licensed medical director following review of all infectious disease testing, the uniform donor risk assessment interview and all relevant medical records.
Tissue is shaped using specially designed clean room equipment and subjected to a proprietary series of processing steps to effectively clean and disinfect allografts without the use of harsh chemicals. Tissue is lyophilized or dehydrated and subjected to post processing evaluation prior to final packaging. Every step of the process is completed in accordance with current Good Tissue Practices (cGTP), AATB standards and AORN aseptic technique. All processes are validated against ISO standards. Following processing, allografts are subjected to terminal sterilization via low dose irradiation to a sterility assurance level of 10-6.
Finally, a comprehensive review of the infectious disease testing, processing records, labeling documentation, and medical records are completed by a dedicated quality associate prior to the tissue being released for distribution.
Allografts are processed on-site at our 17,500 Sq. Ft. facility with over 5,000 Sq. Ft. of clean room space, and are processed in accordance with current Good Tissue Practices under aseptic conditions compliant with AORN standards.
Compliant with all FDA and AATB mandated Good Tissue Practices (cGTP)
Accredited by the American Association of Tissue Banks
Registered by FDA and Health Canada CTO, licensed with the states of California, Delaware, Florida, Illinois, New York, Maryland, and Oregon
Technical quality assurance standards are strictly maintained throughout the entire manufacturing process