A History of Firsts

1995
  • Genzyme manufactures and commercializes CARTICEL, the first and only cell-based therapy for cartilage repair.
  • First patient is treated with CARTICEL in the U.S.
  • Viability assay implemented.
1996
  • CARTICEL biologics license application (BLA) is filed.
1997
  • CARTICEL receives approval in accordance with new FDA cell therapy guidance.
  • It is the first, FDA-approved, biologics license application for cell therapy.
  • CARTICEL is the only autologous cultured chondrocyte product available in the U.S.
2004
  • First rapid automated sterility test for lot release of a biologic.
2006
  • The Study of the treatment of articular repair, first Good Clinical Practice (GCP) study in the U.S. for cartilage repair completed.
2010
  • Identity assay FDA-approved and implemented as part of the final release criteria for each patient lot.

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