By Jeffrey Johnson, New Technology Lead, Merck & Co., Inc., Kenilworth, NJ, USA and Andrew Carass, Associate Director, Technology Management, MilliporeSigma
The last decade in biopharmaceutical manufacturing has brought a considerable amount of change to how drugs are developed and manufactured. Advances in science and technology have resulted in more diversified pipelines with increasingly complex molecules. Seeking faster ways to bring novel drugs to market while meeting stringent product quality requirements, biomanufacturers have become progressively more focused on process intensification. Innovation in areas such as process analytical technology (PAT), single-use technology, and R&D has led to improved productivity and efficiency, resulting in higher titers from the bioreactor and ultimately transforming the future of biopharmaceutical development and manufacturing.
As the industry drives toward increased throughput from modernized facilities, challenges are growing utilizing the legacy systems and processes traditionally used to produce therapeutic proteins. One area specifically is the preparation and delivery of buffers, which are necessary to control pH and stabilize the product of interest during the downstream purification. As titers increase, there is a corresponding increase in buffer volumes needed for downstream purification. The current methods for buffer preparation and management require production of buffers in large stainless steel tanks in a buffer preparation area. This puts a strain on capital expenditures as well as classified facility space, as biomanufacturers must dedicate a sizeable portion of a facility and a large amount of equipment to buffer preparation.