Expertise and Infrastructure.
We develop, manufacture, and launch regenerative medicine solutions that help to support you and your goals.
Aziyo Biologics has an extensive history and experience developing, manufacturing, and launching regenerative medicine products. No one compares when it comes to our capabilities and scientific understanding of cardiovascular, orthopedic, and reconstructive surgery products.
Whether you are looking for a co-marketed partnership, private label product, or a tissue bank, Aziyo is able to support your business needs.
Innovative Medicine.
Unparalleled science and technical capabilities.
In-house Expertise
- Extracellular matrix biology
- Bioengineering
- Cellular biology
- Immunology
- In-vitro test methods
- In-vivo models
- Clinical data generation
- Regulatory processes
State of the Art Facility
- 31,000 sq. ft. manufacturing facility located outside San Francisco, CA
- Dedicated to HCT/P products since 2014
- Experienced team, 80+ employees
- 9 processing rooms (ISO 5 – 8)
- Compliant regulatory profile
- Capable of aseptic processing for non-irradiated products
- Product Development laboratory
Supply Chain Optimization
- Manufacture and ship directly to customers or ship bulk for storage and distribution
- Manufacture and ship directly to customers or ship bulk for storage and distribution
- Forecast models for tissue donor receipt and release are used to ensure manufactured product availability and demand are matched
- > 99 % on time delivery
Science and Product Development Expertise.
Aziyo Can Develop or Enhance Your Product
- Turn-key novel development capabilities
- Next generation product improvement (life cycle management)
You Can Add Our Products to Your Portfolio
- Increase revenue with limited development risk/infrastructure
- Private label or co-marketing partnership options
Source Products from Our Tissue Bank
- Human tissue product supply
- Contract manufacturing
- Bulk tissue products
Our Commitment.
Aziyo is committed to preserving the integrity and safety of all tissues used in the development of its products.Â
Commitment to Quality
All Aziyo tissue is processed in our 10,000-square-foot clean room space. We use cutting-edge technologies that enable us to process and manufacture our tissues using precise, standardized methods that ensure quality and consistency across our products and services.
Safety and Regulatory
All Aziyo tissue undergoes rigorous testing before being released for transplant or distribution to our partners. Aziyo is proud to meet or exceed all industry benchmarks for quality assurance and testing, and maintains compliance with regulatory agencies, including the American Association of Tissue Banks (AATB) and the U.S. Food and Drug Administration (FDA).
The following is a listing of frequently requested registrations, licensure and/or accreditations for Aziyo’s Richmond facility.
FDA
American Association of Tissue Banks (AATB)
State of California
State of Delaware
State of Florida
State of Illinois
State of Maryland
State of New York
State of Oregon
Canada Certification
This information is provided as a convenience to hospitals, surgeons, tissue banks and industry partners. Please contact us with queries about any of our licensures.
Interested in Innovating With Us?
Please contact us to learn more about partnering on your next product.