In this anniversary year, I find myself thinking back on things I once was told would never happen in — or never apply to — biopharmaceutical manufacturing. Initially peripheral (seemingly) topics ease into relevance and, by surprising us, emphasize the importance of keeping our eyes on the big picture(s).
When I was an editorial assistant in the late 1980s, I was told simply to toss press releases related to, for example, anything having to do with centrifuges — on the theory that biomolecules were just too fragile for that sort of action. We now have, use, and value centrifuges after knowledge and instrument designs evolved to address specific needs of large molecules. I was also advised that benchtop bioreactors and laboratory analytical methods were “too small-scale” for commercially minded readers, and anything dealing with the properties of flexible plastic tubing was supposedly too broad in applicability. “Focus on stainless steel,” was the mantra. In the 1990s, I argued with my first associate editor about including news of a wild new technology: PCR! As quality functions gained in sophistication, we grew to understand how laboratory work evolves in parallel with scale-up and clinical production. The current industry knows much more about balancing priorities and streamlining communications among functional groups. This issue’s special report is one measure of how far we’ve come toward considering entire processes, life cycles, and holistic development approaches.
Another big thing that I was once told would never happen: biosimilars (then called “biogenerics”). Biomanufacturers assumed they would never have to worry about losing market share. (Oops.) This month’s supplement includes an article by Bill Whitford on using disposables in biosimilar development. And Paul Calvo discusses in this issue how patent regulations are evolving to protect innovators and follow-on manufacturers alike.
As discussed in our roundtable from the Kalvi Foundation, nanotechnology holds promise for drug delivery, diagnostics, and cell therapy. (Another topic once pooh-poohed: “Personalized medicine will be too expensive and an ethical hot potato.” Again, oops.) This issue’s Elucidation counters another one-time taboo in our bio-universe: the word synthetic. Bioinformatics may dovetail with nanotechnologies as a boon to delivery and targeting. And we may find a number of happy surprises awaiting us as useful tools emerge that were not originally “on our radar.”
Other topics on the horizon include standardization of single-use materials and components. As discussed in this month’s supplement, the ripe time for standardization may generally balance on that tipping point between keeping a field open for innovation and an industry’s comfortable, settled-in maturity. To steal from a James Bond film, however, we should probably “never say never” in this industry.
What’s next, pills?