May 2021: From the Editor

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No matter what topic you delve into these days in the biopharmaceutical industry — e.g., process development, market projections, equipment scaling, quality control, regulatory harmonization — you’ll find a tangled web. Development of vaccines and therapeutics for prevention and treatment of COVID-19 continues to play out against the backdrop of unrelated products in development and others already on the market as short-term manufacturing needs and diversions of contract capacity shift the industry’s focus. This issue provides only a snapshot of how facilities are housing such efforts and how flexible designs can support short- and long-term planning.

The industry was more ready to meet the current challenges than it would have been at any other point in its history. A number of innovations have enabled companies to work quickly while managing risks inherent to such speeds. Vital technologies have become available at just the right time. As the Corning Life Sciences director of scientific applications and technical support teams points out in this month’s BPI Insider summaries, “the rapidity of the vaccine industry’s COVID-19 response stems in part from ongoing adoption of modular production technologies.”

I wonder how many industry newcomers realize what remarkable transformations it has undergone. I remember when authors first began to write about the need to incorporate natural sunlight into facility laboratories — many of which once had been relegated to dark basements. From my first facility tour (at the Chiron plant in Emeryville, CA, in 1989), I recall dark, narrow hallways with piping everywhere. On another early tour, my group had to negotiate one narrow hallway by turning sideways in our ill-fitting protective suits — and I couldn’t help wondering how claustrophobics possibly could work there. Today’s facilities stand in stark contrast: full of bright, sunlit laboratories and spacious hallways lined with windows that allow visitors to view manufacturing suites safely without gowning up. In this issue, Tim Sandle reflects much of these changing perspectives as he reviews options for retrofitting older facilities.

Another major change over the years has been a growing realization of how biomanufacturing processes are tied directly to facility design. When BPI’s managing editor toured a large plant in the early 2000s and asked about quality by design (QbD), one manager dismissed the concept as something that would never work for bioprocessing. “There are just too many variables,” he said. Our senior technical editor recalls asking about applications of high-throughput screening in another case. The answer was, “Oh, that’s just for drug discovery. It doesn’t have any application for biologics.” Now such regulatory and technological factors guide risk management, process development, and facility planning with complex modeling tools to help.

In light of all that, just consider the rapidly developed pandemic vaccines. With modern concepts of process control and product understanding, we can be much more confident in them today than we might have felt even 10 years ago. These successes make the even advanced-therapy facility issues seem more resolvable now than they might have seemed before. Tune in next month for more discussion.

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