Current developments in the biopharmaceutical industry have added significantly to the challenges of designing, building, and operating biopharmaceutical manufacturing facilities. With increasing insights into product requirements and product characterization, the critical path for the development of new products is shifting to process development and manufacturing timelines where speed and flexibility are now more critical than ever. Future manufacturing systems must be agile enough to deliver more types of products in a shorter timeframe.
The traditional business model of highly integrated facilities does not allow for this needed increase in operational effectiveness. A new business model is emerging that focuses on flexibility, operability, and utilization where companies can adapt rapidly to changing market conditions.
Manufacturing simultaneous, short multi-product campaigns to supply clinical material, run conformance lots, build initial inventory, and supply commercial material only adds to the complexity of running a biopharmaceutical manufacturing enterprise.
The new generation options of facility design involve the implementation of single-use technologies and new platform technologies along with a flexible approach to facility integration. With QbD as a significant foundation of facility design, these facilities will be “designed to operate” in order to provide a higher level of flexibility, utilization, and operational excellence.
These facilities implement modular delivery approaches that include rapid deployment options, interchangeability of suites, and smaller footprints that respond to the demands of the new business model of the industry. The ability to move processes in and out of the facility quickly and efficiently can greatly increase the throughput of the facility and permit flexibility in responding to changing manufacturing requirements or deal with process problems. Capacity can be significantly increased by cloning the process equipment and installing additional production trains in available spaces.
At Interphex 2015, IPS will focus on these new technologies and approaches that support this new generation of biomanufacturing assets.