The development of cell and gene therapies goes back over a century. The development of in-depth knowledge about the characteristics in organisms and genetic manipulations and expansion of cells has resulted in the treatment of diseases that were considered terminal few decades ago. In the case of CAR T therapies, significant progress has been reported resulting in the approval of multiple therapies worldwide. The use of ex vivo cell manipulations and expansion bring the need for preservation techniques that ensure no impact to the viability of the modified cells. Cryopreservation is a technique commonly used where cells are frozen and stored at subzero temperature with the confidence of limited or no damage to their viability. DMSO is among the preservation agents utilized for cryopreservation of viable cells. The basic principle of successful cryopreservation and resuscitation is a slow freeze and quick thaw. The use of DMSO contributes to the successful preservation and resuscitation of cells. It is common the use of DMSO in the manufacture of CGT products as a cryopreservative. Typical concentration ranges from 5% to 10% to avoid potential damage to preserved cells. The USP and or EP monographs can be utilized to establish suitable quality for the material prior to use. In terms of processing, sterile filtration is commonly used for solutions containing DMSO. DMSO products shall be processed using a membrane and filter housing compatible with the chemical.

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Use of DMSO in Cell and Gene Therapies

  • Rachael Atlee,
  • Humberto Vega-Mercado

摘要

The development of cell and gene therapies goes back over a century. The development of in-depth knowledge about the characteristics in organisms and genetic manipulations and expansion of cells has resulted in the treatment of diseases that were considered terminal few decades ago. In the case of CAR T therapies, significant progress has been reported resulting in the approval of multiple therapies worldwide. The use of ex vivo cell manipulations and expansion bring the need for preservation techniques that ensure no impact to the viability of the modified cells. Cryopreservation is a technique commonly used where cells are frozen and stored at subzero temperature with the confidence of limited or no damage to their viability. DMSO is among the preservation agents utilized for cryopreservation of viable cells. The basic principle of successful cryopreservation and resuscitation is a slow freeze and quick thaw. The use of DMSO contributes to the successful preservation and resuscitation of cells. It is common the use of DMSO in the manufacture of CGT products as a cryopreservative. Typical concentration ranges from 5% to 10% to avoid potential damage to preserved cells. The USP and or EP monographs can be utilized to establish suitable quality for the material prior to use. In terms of processing, sterile filtration is commonly used for solutions containing DMSO. DMSO products shall be processed using a membrane and filter housing compatible with the chemical.