The evolving role of automation in process development & manufacture of cell & gene-based therapies

Qasim A Rafiq, Robert J Thomas
2016 Cell and Gene Therapy Insights  
The need for automation in cell and gene therapy manufacturing processes is primarily driven by the regulatory requirements for reproducibility, clinical need for consistent, efficacious therapies and commercial constraints of developing scalable, cost-effective processes. Automation has already played a pivotal role in healthcare manufacture, including that of successful vaccine production. However, the role of automation continues to evolve and technologies and platforms are now emerging
more » ... e now emerging which succeed in expediting efforts in process development, facilitating high-throughput approaches, thereby effectively reducing the cost of development and time to market. Moreover, early integration of automation facilitates process transitions at later stages of clinical development and commercialisation. However, meeting the capital costs of developing an automated solution can be challenging, particularly in early development; a strategic decision needs to be made regarding the point in the development pathway automation is introduced, and to what extent. Factored into this decision is the nature of any solution, for example a turn-key automated system or a bespoke platform. Ultimately the extent and nature of any approach will depend on our level of process and product understanding; as this improves, we are likely to see a significant shift toward the adoption of automated solutions.
doi:10.18609/cgti.2016.058 fatcat:7bcstv5nmfdzhfkfxxyt2rgsqa