NovaMatrix - Ultra-Pure Biopolymers and Biomaterials

NovaMatrix is one of the world's leading producers and supplier of ultra-pure, well-characterized and documented biopolymers and biomaterials for use in pharmaceutical, biotechnology and biomedical applications.

The company's current products are special ultra-pure grades of PRONOVA sodium alginate, PROTASAN chitosan base and water-soluble salts, and sodium hyaluronates that fulfil functional and regulatory specifications.

Sodium alginate, chitosan salts and bases, and hyaluronates are manufactured in accordance with cGMP guidelines (Code of Federal Regulations, Title 21, Part 210 and 211), NS-EN ISO 9001:2000 (quality management system) and ISO 13485:2003 (medical device directive) standards.

NovaMatrix is a newly created business unit of FMC BioPolymer, one of the leading suppliers of ingredients to the food, pharmaceutical and specialty products industries.

ULTRAPURE BIOPOLYMERS

NovaMatrix's technology and products are used in the development of novel drug-delivery therapies and its polymers are utilized in the formation of biostructures for tissue engineering, wound healing, implants and advanced biotechnology applications. Alginate, chitosan and hyaluronan have proven properties suitable for parenteral administration of challenging drugs and implants.

PRONOVA UP - ULTRAPURE ALGINATES

PRONOVA UP UltraPure (UP) sodium alginates are manufactured in the specially designed NovaMatrix production facility in Oslo, Norway.

This NovaMatrix product group belongs to a family of highly purified and well-characterized alginates developed for use in biomedical and pharmaceutical applications.

The products are characterized by specified parameters reflecting the key properties and purity profile of the material. Process and final product control are based on validated methods of analysis. Safety and toxicology data are reported in a drug master file submitted to the US FDA.

PRONOVA - STERILE ALGINATES

Sterilizing alginate solutions may often be an obstacle in pharmaceutical and biomedical applications requiring sterility of the applied material. In particular, this relates to problems with polymer degradation during autoclaving or irradiation procedures. Sterile filtration of highly viscous solutions may also be difficult.

To meet customer demands, NovaMatrix offers PRONOVA UP alginate as a sterilized and lyophilized product. Sterile aqueous solutions of sodium alginate may now be made simply by adding sterile water or buffers to the lyophilized alginate. The volume of added solution will thus determine the concentration of the alginate solution. Placing the vial on a shaker facilitates dissolution.

PROTASAN - ULTRAPURE CHITOSANS

The PROTASAN UP product series from NovaMatrix consists of ultra-purified and well-characterized water-soluble chitosan chloride and glutamate salts, and chitosan bases, for use in biomedical and pharmaceutical applications and also includes the newly launched series of six different PROTASAN UP chitosan base products. The new series consists of ultra-purified chitosans in the free amine or base form, with different viscosities.

ULTRAPURE - SODIUM HYALURONATES

Sodium Hyaluronate Pharma Grade is a highly purified and well-characterized sodium hyaluronate developed for use in biomedical and pharmaceutical applications.

Sodium Hyaluronate Pharma Grade is manufactured at the NovaMatrix / FMC BioPolymer strategic partner Kibun's state-of-the-art production facility in Kamogawa, Japan.

The fermentation of ultra-pure sodium hyaluronate is made from non-animal origin material and based on more than 10 years of experience and the plant in constructed and run in compliance with cGMP guidelines for bulk pharmaceuticals. The ultra pure sodium hyaluronates from Kibun are described in a DMF submitted to the US FDA.