ALTASORB
BIOABSORBABLE
MONOMERS

Ortec, as a supplier, offers a range of monomers used in the biomaterials market. These monomers are of the highest quality and are readily available. They are produced in the US and supplied worldwide. Altasorb Monomers are used to manufacture bioabsorbable polymers that are used in pharmaceutical applications and for the production of medical devices.

As a contract manufacturer we can also produce your speciality bioabsorbable polymers from these monomers. This vertical integration combined with our manufacturing capabilities allow us to be highly proficient in custom polymer production.

Ortec can help you foster your product from early process scale-up through full production while maintaining a high level of confidentiality. We have the expertise to help you through process validations and qualification, and we have manufactured products under FDA regulations CFR 210, 211, 810 and 110. We constantly review new regulatory practices to ensure compliance. Ortec has dedicated a 65,000 square foot, state-of-the-art facility to our cGMP manufacturing and related services. Located on 45 acres, this plant includes laboratories, pilot manufacturing suites and full-scale production areas. All chemical handling sections are designed as low particulate environments with 95% filtered air. Our 2,500 square foot validated class 100,000 clean room contains USP water and UV-filtered lights and windows.

PRODUCTS

DL-Lactide
Cas No. 95-96-5
Download specification and data sheet
Download SDS

Glycolide
Cas No. 502-97-6
Download specification and data sheet
Download SDS

Trimethylene carbonate
Cas No. 2453-03-4
Download specification and data sheet
Download SDS

e-Caprolactone
Cas No. 502-44-3
Download specification and data sheet
Download SDS

APPLICATIONS

Bioabsorbable Polymers manufactured from these products are used in many applications and our customers are continuing to develop new applications.  The most common are:

  • Controlled release systems
  • 3D printing
  • Orthopedics
  • Tissue regeneration
  • Wound management
  • Cardiovascular

QUALITY

  • Offer full cGMP services
  • CFR 210, 211, and 810 capability
  • Experienced team available to meet customer auditing requirements
  • Excipient Manufacturing to IPEC Guidelines
  • EudraLex Volume 4 EU GMP

SERVICES

In addition to being a world class supplier of monomers, as a contract manufacturer we can also offer derivatives of these monomers as part of our chemical manufacturing capabilities.

The innovative work of our researchers continues to expand the range of capabilities we can offer, such as:

  • Free Radical Polymerizations for Emulsions and Solutions
  • Condensation Reactions and Polymerizations

HOW CAN ORTEC HELP YOU?

Are you considering outsourcing your chemical manufacturing? Want to free up your assets to focus on other projects? Need a partner who has the quality systems and regulatory knowledge to meet your demands? Someone who can hit specs, improve efficiencies, and get you quickly to market without going over budget?

 

CONTACT US TODAY

Back to Top