Rapid Implementation of Continuous Manufacturing

We developed a GMP modular continuous processing system that lowers the hurdles of adopting new technologies. This technology was designed to (1) meet drug product demand, (2) provide modular, mobile manufacturing, and (3) reduce environmental impact. Demand for Covid mAbs increased 20X in 2.5 months. To meet such demand, the system increases manufacturing capacity by employing continuous processing. The off-the-shelf system runs any four unit operations simultaneously, resulting in 4X more product. The modular design accommodates different products and processes. Single-use product-contact surfaces allow for quick changes between products. The system is fully closed, can roll through a standard door, and plug into a standard outlet, allowing deployment in various locations. Environmental impact is minimized with compact, single-use equipment, eliminating the need for CIP and SIP systems. Combining four steps shrinks facility footprint requirements another 60%. The system was designed with ease of implementation in mind. Despite operating in a continuous manner, the control strategy ensures batch key process parameters can be maintained in most if not all cases, reducing the burden on process development and process validation activities. This fact, and familiarity of the system by regulatory agencies, reduces unknowns and speeds adoption of this novel technology.