Technology


 

Manufacturing

PuraMatrix™ peptides are produced by well-characterized F-MOC solid-phase peptide synthesis methodology with proprietary processing modifications. The peptide is fill-finished via proprietary aseptic fill-finish and quality testing steps: formulation in liquid, sterile filtration, specification and adjustment of concentration, aseptic fill into vials or syringes, packaging, validation and documentation. Certification of fill-finish manufacturer includes ISO 90001:2000 and ISO 13485, with inspection by the FDA.

 

Quality

PuraMatrix™ has been tested across multiple standard animal models and in multiple tissue compartments (bone, cartilage, muscle, CNS, intracutaneous injections) - without a single negative safety outcome. This quality is due to PuraMatrix™’s low concentration of fully synthetic, short-length peptides composed of only three standard amino acids forming a biocompatible, biomimetic and bioresorbable nanofiber network structure.