CDMO for regenerative medicine: processing and manufacturing of allograft and xenograft biomaterials into surgical implants.
Evergen Biologics
Alachua (Florida, USA) · West Lafayette (Indiana, USA) · Eden Prairie (Minnesota, USA) · Glencoe (Minnesota, USA) · Neunkirchen am Brand (Germany) · Marton (New Zealand) · Glasgow (Scotland)New on Amplifa
About Evergen
Evergen is a Contract Development and Manufacturing Organization (CDMO) for regenerative medicine headquartered in Alachua, Florida (USA). The company processes human donor tissue (allografts) such as dermis, pericardium, fascia lata, bone, cartilage, tendons, skin, cornea and sclera as well as xenogeneic tissue from pigs and cattle into surgical implants. Processes include the proprietary sterilization processes BioCleanse®, Tutoplast® and Cancelle SP®, terminal gamma sterilization with a sterility assurance level of up to 10-6, precision machining of bone, collagen formulations (gels, sponges, sheets, powders, foams, membranes), freeze-drying and heart valve sewing technology. In addition to manufacturing, Evergen provides biomaterial procurement with allograft screening and infectious disease testing, product development, design and process engineering, regulatory support (361 HCT/P, 510(k), IDE, PMA, CE marking), QA/QC lot release, packaging, drop shipping and inventory management. Customers are medical device OEMs in fields such as plastic and reconstructive surgery, sports medicine and orthopedics, neuro/spine and cardiovascular surgery. The quality management system is ISO 13485 certified; sites exist in the USA, Germany (Neunkirchen am Brand), New Zealand and Scotland.
- Site
- Alachua, FL (USA)
- Processes
- Tissue processing into surgical implants (allograft/xenograft), BioCleanse® Tissue Sterilization Process, Tutoplast® Tissue Sterilization Process, Cancelle SP® Sterilization Process, Proprietary SIS Processing, Precision machining (bone/tissue), Valve sewing and manufacturing (heart valves), Custom formulations (collagen formulations: gels, sponges, sheets, powders, foams, fibrous
- Materials
- Allograft Dermis, Allograft Pericardium, Allograft Fascia Lata, Allograft Mineralized & Demineralized Bone, Allograft Fibers, Allograft Bone, Allograft Cartilage, Allograft Tendons
- Certificates
- ISO 13485
- Founded
- 1998
- 01
Biomaterial procurement (allograft screening, infectious disease testing,
- 02
Product development / R&D / prototyping
- 03
Design and process engineering
- 04
Tissue processing and precision machining
- 05
Sterilization (BioCleanse, Tutoplast, Cancelle SP, gamma)
- 06
QA/QC lot release
- 07
Regulatory support
- 08
Packaging, logistics and distribution
Biomaterials & Process Technologies
BioCleanse® Tissue Sterilization Process
Automated, pharmaceutical-grade sterilization system with SAL 10-6; removes blood, lipids and pathogens while preserving the biomechanical and biochemical integrity of the tissue.
Tutoplast® Tissue Sterilization Process
Combination of osmotic, oxidative and alkaline treatments with solvent dehydration and low-dose gamma irradiation for terminal sterilization.
Cancelle SP® Sterilization Process
Sterilization of DBM and corticocancellous chips through oxidative treatments, acid or alcohol washes and terminal low-temperature gamma irradiation (SAL 10-6).
Gamma Irradiation (Low-Dose, Terminal)
Terminal sterilization of the packaged graft with a sterility assurance level of up to 10-6.
Porcine Small Intestinal Submucosa (SIS) Processing
Proprietary process that removes living cells, inactivates viruses and preserves the fibrous-porous extracellular structure; form factors as wraps, tubes, plugs and sheets.
Freeze-Drying / Lyophilization
Preservation of collagen in standard and long-fiber formulation for storage without a cold chain.
Precision Machining of Bone
Machining of allograft and bovine bone as well as bovine tendon into customized implant geometries.
Heart Valve Sewing Technology (Valve Sewing)
Manufacturing of percutaneous and surgically implanted heart valves made from fixed xenogeneic pericardial tissue.
Collagen Engineering
Custom form factors made from pepsin- or acid-solubilized, fibrillar and freeze-dried collagen as gels, sponges, sheets, powders, foams and fibrous membranes.
Allograft Biomaterials
Human donor tissue (dermis, pericardium, fascia lata, mineralized/demineralized bone, fibers, bone, cartilage, tendons, skin, cornea, sclera) to support natural healing.
Xenograft Biomaterials
Tissue from pigs and cattle from BSE-free countries such as Australia and New Zealand or from closed herds, manufactured in ISO 13485-certified facilities.
Sites
Alachua
USHeadquarters and manufacturing site (tissue processing, sterilization, donor services)
- Materials
- Allograft and xenograft tissue, collagen
- BioCleanse® automated pharmaceutical-grade sterilization system
West Lafayette
USSite
Eden Prairie
USSite
Glencoe
USSite
Neunkirchen am Brand
DESite Germany
Marton
NZSite New Zealand
Glasgow
GBSite Scotland
Components
Inside the production
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Tissue processing into surgical implants (allograft/xenograft)Plastics | – | – | – | – | Allograft Soft Tissue, Allograft Musculoskeletal, Xenograft Soft Tissue, Xenograft Bone |
| BioCleanse® Tissue Sterilization ProcessSurface | – | – | – | – | Allograft, Xenograft |
| Tutoplast® Tissue Sterilization ProcessSurface | – | – | – | – | Allograft, Xenograft |
| Cancelle SP® Sterilization ProcessSurface | – | – | – | – | Demineralized Bone Matrix (DBM), Cortical Cancellous Chips (CCC) |
| Proprietary SIS ProcessingPlastics | – | – | – | – | Porcine Small Intestinal Submucosa (SIS) |
| Precision machining (bone/tissue)Machining | – | – | – | – | Allograft Bone, Bovine Bone, Bovine Tendon |
| Valve sewing and manufacturing (heart valves)Assembly | – | – | – | – | Xenograft Fixed Tissues, Pericardium |
| Custom formulations (collagen formulations: gels, sponges, sheets, powders, foams, fibrousPlastics | – | – | – | – | Collagen (pepsin-solubilized, acid-solubilized, |
| Freeze-drying / LyophilizationPlastics | – | – | – | – | Collagen |
| SterilizationSurface | – | – | – | – | – |
| Molecular and biochemical assaysTesting | – | – | – | – | – |
| Biocompatibility assessments and assaysTesting | – | – | – | – | – |
| Allograft screening, infectious disease testing and medical releaseTesting | – | – | – | – | Allograft |
| Xenograft sourcing and screeningTesting | – | – | – | – | Xenograft |
| Concept prototyping and testing / Design and process engineeringEngineering | – | – | – | – | – |
| Packaging solutions and distribution / Drop shipping / Warehousing and inventory management /Assembly | – | – | – | – | – |
| Low-dose gamma irradiation (terminal sterilization, SAL 10-6)Surface | – | – | – | – | Allograft, Xenograft |
1 Anlagen & Maschinen
| Machine | Manufacturer / model | Quantity | Working area | Year built | Site |
|---|---|---|---|---|---|
| BioCleanse® automated pharmaceutical-grade sterilization system | BioCleanse® | – | – | – | Alachua, Florida (among others) |
Additional services
Quality & Certifications
Evergen operates an ISO 13485-certified quality management system across multiple sites and has extensive experience with 361 HCT/P, 510(k), IDE and CE marking. The scope of services includes QA/QC lot release testing, molecular and biochemical assays as well as biocompatibility testing; the company participates in the voluntary Medical Device Discovery Appraisal Program (MDDAP).
| Evidence | Alachua | West Lafayette | Eden Prairie | Glencoe | Neunkirchen am Brand | Marton | Glasgow |
|---|---|---|---|---|---|---|---|
| ISO 13485 |
History
- 1998
Company founded
- 2017
Olivier Visa joins as OEM Franchise Leader
- 2020
Olivier Visa becomes President & CEO in July
- 2026
Award "Best Overall MedTech Company" at the MedTech Breakthrough Awards (10th edition)