This presentation will discuss next generation biomanufacturing which can significantly reduce a facility’s footprint, capital investment, manufacturing cost of goods and improve utilization of assets when compared to conventional batch processing. In response to the uncertainty of ever-changing product pipelines, the biotech industry has recently been evolving to develop flexible manufacturing solutions that can be quickly mobilized to provide a nimble response to changes in production demands. The industry has concurrently improved its ability to assess and control the risk to the manufacturing process by engineering solutions to improve the closure of the process. However, these flexible manufacturing solutions come with capacity limitations that can inhibit their applicability for certain larger scale applications. The advent of continuous processing technologies opens the door to coupling upstream and downstream unit operations to achieve a viable solution for end to end continuous manufacturing of bulk drug substances. Compounding the benefits of other enabling technologies – continuous closed processing and implementation of single-use systems, where appropriate – results in a next generation biopharmaceutical manufacturing facility that significantly reduces the facility footprint, capital investment, manufacturing cost of goods, and improves utilization of assets when compared to conventional batch processing.
At the conclusion of this education session, participants will learn how the implementation of continuous closed processing impacts the design of biopharmaceutical manufacturing facilities, be able to analyze the impact to cost of goods for manufacturing therapeutic proteins using a continuous closed process relative to a conventional batch process and understand some of the risks and barriers to entry limiting the implementation of continuous closed processing technology.
Speaker: Matthew Kennedy | Bioprocess Engineer, CRB
Named a 2015 Top 20 Under 40 Award Winner by ENR Mid-Atlantic, Matthew Kennedy is a Bioprocess Engineer whose designs have been on the cutting-edge of technology and have helped to establish him as an industry expert with specialized knowledge in closed processing, single-use technology, flexible manufacturing, and continuous processing. His facility design experience spans the breadth of the biotechnology industry with applications in monoclonal antibodies, vaccine and blood fractionation manufacturing facilities.
Matthew has held a leading role on several ISPE facility of the year award winning projects (Bristol-Myers Squibb’s Clinical Manufacturing Facility in 2016 and Shire’s HGT facility in 2011). He is an active biotech industry member, regularly participating in groups like the International Society for Pharmaceutical Engineering (ISPE), Biotechnology Industry Organization (BIO) Pennsylvania Chapter. Matthew has been published in Pharmaceutical Engineering Magazine, presented at Interphex, ISPE, Bio-Process Systems Alliance (BPSA) and the ASME Bioprocess Technology Seminar.