Quality Systems For Continuous Manufacturing
Continuous manufacturing is a familiar concept in large volume commercial commodity operations such as glass and plastic production. In the wake of the Tylenol cyanide poison scare in the 1970’s, pharmaceutical production at the J&J subsidiary McNeil converted to virtually closed, continuous manufacturing. Several Biotech firms tried to develop fermentation unit operations in the 1990’s that were based on the continuous manufacturing concept. Today there are a number of initiatives to update and realize the concept from bench top, such as MIT and Novartis’ sponsorship of start up firm Continuus’ production of solid dosage forms in Boston, to biodefense tractor-trailer sized factories for battlefield manufacturing of antidote injections being developed by DARPA.
Requirements for monitoring and controlling biomanufacturing of biopharmaceuticals during continuous production to ensure process robustness, product safety and product quality can be addressed by a Quality System that focuses on the linkage of product and process data between Development, Engineering, Manufacturing, Quality Control and Quality Assurance. Understanding the product quality attributes and the process impact on them is essential to process design and selecting the in-line controls and analytical tools to be employed. This presentation will address the issues facing the industry and practical Quality System solutions.