Issue of Container Closure Integrity at Cell & Gene Therapy Products
Information
The development of new modalities, cell and gene therapy (CGT) products, has been accelerated recently. CGT products are "living drugs" and require much stricter ultra-low or cryogenic temperature control than the conventional drugs.
Conventional small molecule drugs and biologics have mainly adopted glass containers. However, under freezing conditions, they cause cracking issues by drug expansion and heat cycle stress. In addition, since the coefficient of thermal expansion of glass and rubber is about 10 times different, which creates small gaps between them at freezing temperatures, failure of container closure integrity has been reported.
COP or COC containers are mainly used for the CGT products alternatively, but they have a disadvantage of poor gas barrier properties that causes CO2 permeation after dry-ice storage and pH shift.
Under these circumstances, we have developed OXYCAPT multilayer plastic vial made of COP and high gas-barrier polymer that prevents CO2 permeation and pH shift.
