YOUR BIOMATERIAL SOLUTIONS PARTNER for innovative bioresorbable medical devices
Evonik Health Care is one of 8 business lines of Evonik’s Nutrition & Care segment which employs approximately 7,500 employees, and generated sales of around €4.3 billion in 2016.
The Biomaterial segment of Evonik Health Care, with a history of over 30 years, develops and markets a broad range of biodegradable polymers for medical devices and parenteral controlled release applications as well as for regenerative medicine applications.
Bioresorbable plates and screws for trauma and orthopedic applications, bioabsorbable stents and coatings for next generation cardiovascular treatments are just a few products made by our RESOMER® family of bioresorbable polymers.
Products:
RESOMER®: Full range of bioresorbable polymers derived from lactide, glycolide, trimethylene carbonate, p-dioxanone and ε-caprolactone:
- Amorphous elastomers to semi-crystalline solids with melting points up to 185 °C
- Semi-crystalline polymers: PLA, PCL
- Amorphous PDLA, PDLGA and other copolymers
- Water-insoluble
- Proven safety track record
- No adverse reactions
- Easy processing
- Stable after sterilization
RESOMER® Select: Designed to meet your exact needs:
- Any polymer outside our standard range
- Customization – all products are made to order:
- Monomers, monomer ratios, end groups, inherent viscosities…
- Whatever you require, whatever you imagine
- Batch sizes to reflect your needs.
The advantages of RESOMER® polymers:
- Proven safety track record
- No adverse reactions
- Complete metabolization
- Easy processing
- Stable after sterilization
Novel biomaterial development:
As our partners in the medical device industry discover new ways to use the body's own regenerative and repair potential, Evonik is there to bridge the gap between concept and reality. We provide the technical capabilities and access to cGMP facilities you need to drive your novel biomaterial concepts to market.
The areas we look forward to exploring with you are:
- Smart biomaterials: dynamically responsive biomaterials, conductive polymers
- Biomaterials for cellular production
- Biomaterials and scaffolding for bone regeneration
- Biomaterials and scaffolding for neural regeneration
- Cardiovascular biomaterials
- Orthopedic biomaterials
- Dental biomaterials
- Tissue engineering
Medical Device application laboratories:
Medical Device companies are looking for partners who can help them with reliable supply of materials and support on how to best use these materials for their specific design and production needs. Design, develop, and scale-up your medical devices with the support of our medical device application laboratories in Germany and China.
We are in a position to assist our customers with:
- Selection of the most suitable RESOMER® polymer for the application
- Characterization of production process conditions (injection-molding and extrusion) for successful design and scale-up
- Manufacturing of technical samples for feasibility studies
Evonik’s service offering allows you to:
- Reduce research and development time
- Increase speed to market with global access
- Troubleshoot development or production issues
Both of our medical device application laboratories have state of the art equipment available to address our customers’ design, development, scale-up, and technical requirements.
Analytics:
- Inherent viscosity (IV)
- Residual monomer content
- Mechanical testing (EN ISO 527-2)
What makes Evonik your right choice for bioresorbable polymers?
Expert partner:
- Breadth of technical knowledge
- Support from development through commercial manufacturing
- Technical and analytical support services available
Quality & regulatory:
- ISO 9001 & 13485 certification
- IPEC-GMP Good Manufacturing Practices Guide for Pharmaceutical Excipients, 2006
- Master Files & Technical Dossiers maintained
- Broad in house analytical capabilities
Ideal biomaterial:
- Standard product offerings with a wide range of physical properties. Custom blends available
- 30-year commercially proven history of safety and efficacy
- Fully resorbable
- Can be processed using conventional manufacturing methods
- 5-year shelf life
Security of supply:
- Full range of inventory maintained
- Safety stocks
- Dual sourcing capability
To find out more about RESOMER® products and services please visit www.evonik.com/resomer or contact us at resomer@evonik.com