The biologic solutions clinicians prefer, delivering the trusted results they expect.

Maxxeus products have been utilized for over 30 years and provide safe and high quality options for the best clinical outcome. With decades of expertise in providing biologics, we understand the needs of physicians. Because we focus exclusively on biologics, Maxxeus can provide our customers and their patients the best biologic options available. Maxxeus provides tissue for more than 7,000 hospital and physician clients across the nation.

We provide a large portfolio of allograft tissue that has been developed specifically to meet our customer’s needs. With a robust Process, Engineering and Development program, Maxxeus uses science and innovation to develop the newest technologies. Our portfolio continues to expand as innovative technologies develop and techniques evolve.

Patient safety and physician satisfaction are our priorities. We only approve donors that meet or exceed donor eligibility requirements set in place by the Food and Drug Administration (FDA), American Association of Tissue Banks (AATB), state regulations, and in-house Licensed Medical Directors.

Biologics Safety:

All musculoskeletal grafts recovered by our tissue centers and partner Organ Procurement Organizations (OPOs) across the United States are processed at Solvita’s processing center in Kettering, Ohio. All of Solvita’s valued OPO partners are trained and audited by Solvita to ensure recovery operations are compliant with all applicable regulations. All donors are recovered within the United States.

All partners performing recoveries for Solvita are registered with the FDA.

All donors are recovered using aseptic technique in an environment that meets or exceeds the standards set by the FDA, AATB, and Solvita’s Standard Operating Procedures.

As an added measure of safety, and to reduce the risk of transmission of Creutzfeldt-Jakob disease (CJD), Solvita does not recover tissue from the spinal column or Dura, as these areas have a higher potential for carrying the prion associated with CJD transmission.

Testing:

Prior to clearance for processing, donor medical records, including the donor’s medical and social history, physical assessment, and autopsy results (if performed), as well as all other recovery documentation, are reviewed by Solvita’s Medical Directors. All Solvita donors are tested for transmissible diseases using FDA-licensed, approved, or cleared donor screening test kits. Additionally, each individually recovered tissue undergoes pre-processing microbiological cultures to ensure pathogenic organisms are not introduced to the processing environment.

Processing:

All musculoskeletal tissue grafts recovered by our tissue centers and recovery partners across the United States are processed in Ohio and then distributed around the country from our processing center or one of our five branches. Strict processing procedures are performed by Solvita to ensure quality and safe tissue grafts for transplantation. Solvita complies with guidelines and regulations from the AATB, FDA and many other state health departments.

Allograft Sterility:

Grafts labeled as have been sterilized to a Sterility Assurance Level of 10-6 (SAL) in their final packaging following ISO 11137 Method 2B. A 10-6 SAL means the probability of a graft being non-sterile is 1 in 1,000,000. Solvita chose Method 2B and employed a two-media approach for conducting sterility testing because it represents a conservative methodology, well suited for the variations of bioburden inherent in human tissue.

Aseptically processed tendon allografts are manufactured in an ISO Class 5 environment, following rigorous quality assurance standards. The sterility of the final product is tested using microbiological verification testing per USP <71>, Sterility Tests. Grafts are released for transplantation with final culture results that demonstrate no bacterial growth.

​Solvita’s Processing Facilities

Solvita’s processing facilities are among the most advanced facilities in the world devoted to the development, production and distribution of biologics. Designed and built from the ground up with quality and safety in mind, capabilities include:

  • ISO 13485 certification
  • AATB, CLIA, FDA registration (click here to view certificates/accreditations)
  • 38 ISO Class 5 clean rooms
  • Dedicated air handling and filtration for each clean room
  • 400,000 sq. ft. of risk adverse warehousing space

In 2023, Solvita and our partners have recovered tissue from more than 12,000 donors and distributed more than 1.2 million grafts to communities around the world.

Solvita

Maxxeus is a brand of Solvita. Solvita began operations as the Community Blood Center in September 1964 and opened Community Tissue Services to process allografts in 1986. In 2023 Community Blood Center/Community Tissue Services updated our name to Solvita. As a not-for-profit, 501c(3) organization, Solvita delivers the confidence and tradition of 60 years of service to the customers it serves. Solvita is a founding member and accredited by the American Association of Tissue Banks.

In addition to our facilities in Dayton and Kettering, Ohio, Solvita has tissue center locations in the following areas:

  • Boise, Idaho
  • Fort Worth, Texas
  • Medford, Oregon
  • Memphis, Tennessee
  • Portland, Oregon
  • Toledo, Ohio

For more information on Solvita, please visit www.solvita.org.