Tissue Engineered Medical Products

As per FDA Guidance for Application for a Surgical Mesh and ASTM F2903: TEMPs for Reinforcement of Tendon and Ligament Surgical Repair, there are specific tests being required for TEMPs whose function is to provide mechanical support, whether temporary or permanent.  Zymetrix' services in this area cover those required to establish physical properties, characterize proteins when biological tissue is used, and analyze cellular behaviour if the product has a live cellular component.

Analysis of matrix components: proteins, collagen, water content

  • methods include gel electrophoresis, Western Blot, ELISA

Cellular analysis

  • Cell distribution and viability via Histology
  • Protein, DNA and RNA extraction and purification
  • Picogreen analysis for quantitative determination of DNA content
  • Assessment of cell viability using MTT and/or XTT assays
  • Gene and protein expression using RT-qPCR

Specific  examples of ASTM  testing protocols that Zymetrix offers in relation to TEMPs include the following: 

  • ASTM F2212: Type 1 Collagen as a starting material for TEMPs
  • ASTM F2347: Hyaluronan as starting materials for TEMPs
  • ASTM F2883: Characterization of ceramic/mineral scaffolds for TEMPs
  • ASTM F2739: Cell viability within biomaterial scaffolds

Mechanical Properties (all to applicable ASTM standards)

tensile properties mesh thickness
suture pull-out strength pore size
burst strength mesh density
tear strength abrasion resistance
fatigue creep/hysteresis