Cell and gene therapies have increased in popularity in recent years, and thanks to their ability to provide one-time treatments these therapies will play a significant role in treating some of the world's most challenging diseases. These drug products treat patients afflicted with genetic disorders and cancers by targeting the source of disease and altering its genetic makeup to eliminate its cause or symptoms. These therapies are expensive and complex and have been proven effective in numerous cases, but they present a challenge in producing them at scale and at a reasonable cost.
Aseptic fill finish of these therapies is especially complex and requires precision to ensure that the final therapy is safe for the intended patients. For cell & gene therapies the batch size is usually very small, and the cell or gene therapy must be produced quickly (within a 2 to 3-hour timeframe) due to its inability to withstand storage at room temperature. Because of this, the fill finish process must be performed rapidly without compromising the quality of the therapy.
Each product in AST’s line of fill finish platforms is specially equipped to support you in all stages of production, from R&D to commercial production. AST can provide the right container system that will work in a scalable process, and be compliant with all regulatory requirements