Product quality specifications and cryopreservation

  • Prior to release, each lot of Dermagraft must pass USP sterility (14-day), endotoxin, and mycoplasma tests; each lot meets release specifications for collagen content, DNA, and cell viability1
  • The human fibroblast cells are from a qualified cell bank1
  • Manufactured with sterile components under aseptic conditions within the final package1
  • Dermagraft must be stored continuously at -75°C ± 10°C1 and has a shelf-life of up to 6 months from the time of cryopreservation3
  • Cryopreservation enables testing prior to shipment and helps with inventory control5
  • Supplied frozen in a clear pouch containing one piece of approximately 2 in × 3 in (5 cm × 7.5 cm) for a single-use application1
  • To ensure the delivery of metabolically active, living cells to the patient’s wound, do not hold Dermagraft at room temperature for more than 30 minutes1

Do not use Dermagraft after the expiration date indicated on the labeled unit carton. Always thaw and rinse product according to the Preparation for Use instructions (in the Dermagraft Directions for Use at www.dermagraft.com) to ensure the delivery of metabolically active, living cells to the patient’s wound.

References: 1. DERMAGRAFT Directions for Use. Organogenesis. 2013. 2. Marston WA, et al. Diabetes Care. 2003;26(6):1701-1705. 3. Data on file. Shire Regenerative Medicine. 2013. 4. US Food and Drug Administration. Medical Devices. Premarket Approval. http://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmissions/premarketapprovalpma/default.htm. Accessed February 6, 2013. 5. Roberts C, et al. Can J Plast Surg. 2002;10(suppl A):6A-13A. 6. Loots MAM, et al. J Invest Dermatol. 1998;111(5):850-857. 7. Margolis DJ, et al. Diabetes Care.1999;22(5):692-695. 8. Brem H, et al. Plast Reconstr Surg. 2006;117(7 suppl):S193-S209. 9. Gentzkow GD, et al. Diabetes Care. 1996;19(4):350-354.