Advanced therapies are being produced using new processes and in unique environments, such as hospitals, translational facilities, and facilities for small-scale manufacturing. These changes have created challenges for cGMP compliance.
In addition, developing medicine by using living organisms must consider their changing nature, which makes guaranteeing consistency a more difficult task when compared with making drugs through chemical reactions.
Cell therapy manufacturing involves a key attribute of sterility assurance, since the final product cannot be sterilized. However, human intervention allows for variability and risked sterility. So, these manual processes can mean contamination or inconsistent therapies.
Automation continues to offer novel options for optimized production and flexibility in biologic production. To advance patient care, we should explore automation and its use in advance therapy manufacturing, resulting in improved quality, safety and compliance.
Automation simplifies the collection and comparison of large numbers of data points. Automating a unit operation with an eSOP reduces hands-on time and the risk of human error. Automating the whole workflow with an electronic batch record raises productivity further while reinforcing GMP compliance.