Conference Theme — Bioprocessing 3.0

The Nobel Prize winning sub-atomic physicist Murray Gell-Mann was recently asked his thoughts on living in the 21st Century and replied, “Today the network of relationships linking the human race to itself and to the rest of the biosphere is so complex that all aspects affect all others to an extraordinary degree. We must therefore study the whole system, however crudely that has to be done, because no gluing together of partial studies of a complex nonlinear system can give a good idea of the behavior of the whole.”

This prescient observation applies in equal measure to bio-products manufacturing, which faces an increasingly challenging future amid growing certainty that current practices must change. Bioprocessing has experienced a near exponential increase in complexity over the past quarter century, such that the human operator is now faced with a system and associated set of information that cannot be easily understood using simple concepts and empiricism. Indeed, the ever higher production rates required in modern bioprocessing plants will soon no longer allow for human-operator-assisted optimization and control using traditional tools and algorithms. Success in high standard of living countries, where much of biologics manufacturing is currently conducted, will therefore require quality assurance through sophisticated process automation that maintains international competitiveness through workforce reductions and nimble real-time process adjustments. This means that highly innovative paradigms and technologies, as well as convergence of those technologies, will be required to effectively create and manage emerging manufacturing processes and multidisciplinary collaborations. With “Bioprocessing 3.0”, we therefore envision a new platform, comprising guiding principles and innovations, that our industry may use to affect these necessary changes.

Bioprocessing 3.0 is about better connecting people, systems and machines. Information is delivered quickly and in much more meaningful ways that facilitate rapid and correct decisions. This will require a completely new kind of process development and management platform that eschews silos for corporate planning, product design, manufacturing execution, supply chain logistics, quality management, manufacturing intelligence, analytics, and so on. The future Development and Management Platform will be a seamless system with information flowing upstream and downstream, and across organizational structures, throughout the life-cycle of process design and operations.

Potent tools for process design, optimization and control must be developed, along with digitized repositories of process knowledge and the value chain that enable manufacturers to share and standardize best practices and protocols. Processes and workflows will thereby be designed and implemented better and faster, leading to significant business advantages that facilitate continuous process improvement and that accelerate cost-effective introduction of new products and product classes.