Quality and Regulatory Issues Related to Continuous Manufacturing of Biologics

Sammanfattning: Introduction: Continuous Manufacturing involves the continuous feeding of input materials into the transformation of in-process materials within, and the concomitant removal of output materials from a manufacturing process based on ICH guideline. In these systems, all the processes from raw material to final finished product would be continuously produced. The project aims to: Investigate the challenges and issues of producing a drug from API (Active Pharmaceutical Ingredient) to the final product using “Continuous Manufacturing (CM)”. Methods: In several interviews, with experts from pharmaceutical companies, information is gathered about the challenges which exist for them to transfer a production line from a batch-based system to a continuous manufacturing line. Moreover, a designed process would be chosen and a comparison study will compare the challenges of transferring the process to a continuous manufacturing while focusing on the regulation and GMP issues. Results: It was concluded that from a regulatory point of view, authorities are welcome to any changes as long as the manufacturer could provide data that they have complete control on the process. However, it is harder for manufacturers to convince the authority for the conversion for their production line to CM compared to starting a new production line with CM systems. Conclusion: It was conducted that converting batch systems to CM is not economically beneficial for manufacturers. Due to this reason CM system would be only beneficial when there is a high demand for a product or a new production line is going to be built.