Cell and cell-based gene therapies continue to show outstanding treatment potential against rare and life-threatening illnesses.
The supply and qualification of starting materials, such as peripheral blood and bone marrow, required to produce the therapy, is still a challenge many researchers must overcome. An ideal starting material has a high capacity for expansion, providing consistent manufacturing, reduced qualification burden, and a high output of individual doses. However, even if the developer is working with an ideal starting material, manufacturing processes may limit the ability to capitalize on beneficial characteristics without improving capacity to produce continuous batch manufacturing.
The ability to perform manufacturing in a closed system, with minimal labor input, can allow for an economical process that reproducibly generates products and meets quality expectations. Continuous, closed-system manufacturing offers the potential to allow implementation of standardized processes early in development, with higher throughput in the same systems through longer batch cycles and automation.
This category of references explores the relevance of flexible, closed-system manufacturing, better packaging, and future scale-up functions as CGT manufacturing advances. The articles cited were authored by BioLife scientists or our customers to evaluate the benefits of cell processing and handling tools designed specifically for CGT.