From the Editor November 2015

Along with products and processing operations moving upstream and downstream, they also move toward the mainstream. The ramifications can become so interconnected that it is hard to discern cause and effect. One example from the past 10 years is single-use materials moving into larger scale processing. That in turn has driven much exploration into flexible operations and variations of continuous processing — neither particularly new concepts, but both now taken into more (potentially) economical directions. Related discussions are bringing heightened attention to sustainability, costs/pricing, and the future of personalized therapies and vaccines. Single-use options and automation are now essential to achieving the cost savings needed to drive down the price of final products.

Single-use technologies drive attention to ongoing factors behind industry successes. We’ve long talked about ensuring the quality and consistency of incoming raw materials and ensuring their sourcing throughout a product’s life cycle. We are used to a certain level of standardization with other production and processing components and tried-and-true documentation for incoming materials. But those norms evolved so gradually that it’s hard to understand why we cannot impose standardization of disposables now without hampering innovation. Distinguishing between user and supplier perspectives in creative partnering arrangements always have been part of the creative side of bioprocessing, but increasing sophistication of available tools and the pressure to cut costs are making such collaborations increasingly critical. That in turn places pressure on corporate legal advisors to define those relationships and on regulators around the world to keep up with related science and technologies.

For example, bioreactor designers increasingly consider adherent cells grown for regenerative medicines along with ergonomic, economic, and sustainable use. Cell therapy speakers sound quite like those discussing monoclonal antibodies in the early 1990s: “How do we get them out of laboratories and safely to scale?” Biosimilar development pushes cost questions even further, and personalized medicines (e.g., Dendreon’s Provenge cancer vaccine) take the discussion in a completely different direction.

Meanwhile, a younger generation is moving into industry leadership, both unburdened by and sometimes not knowledgable enough about how and why processes have evolved to their present state. All too often we see a tendency to jump to an “easy” solution without factoring in the chaotic complexity of interconnected elements. Drug pricing is even becoming a presidential campaign issue, and related analogies need better examination. Should conventional pharmaceuticals and (especially) personalized medicines operate within the same reimbursement paradigm? And without bioindustry’s taking an approach to better informing the public (and politicians) about its work, how can a one-size-fits-all approach do anything but threaten the future brave new world of healthcare?

This month BPI reveals the crossover of concerns among different product types and industry segments. Next month, we will challenge bioexecutives to look deeper into these issues and consider how they can address the challenges of risk management, sustainability, and cost reduction to seize the opportunities that biotechnology presents for improving (and saving) patients’ lives.