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I’ve been enjoying the inevitable social-media debate over whether we’re starting a new decade now or next year. Editors adore that sort of thing — but as much as I love accuracy, I must admit that I’m in the “now” camp. Welcome to the ’20s, anyway, whether or not you think that’s equivalent to “the second decade of the new millennium.” We humans love patterns and milestones, so watching the odometer tick over always brings about a sense of nostalgia and taking stock.
For the biopharmaceutical industry, the 2000s were all about industry maturity and the realizations that come with it. Emerging single-use technologies were all the rage, and companies were trying to figure out how the quality by design (QbD) paradigm was going to change how they work. Biosimilars were an imminent threat (or opportunity, depending on your point of view), and manufacturing capacity questions lingered from the turn of the century onward. We saw a lot of hype about personalized medicine, but little reality beyond the expansion of companion diagnostics. Investors were still head-shy about gene therapies. And when I asked people about “-omics” and high-throughput screening, they often shrugged me off: “That’s just for drug discovery.”
How things have changed. The 2010s brought a focus on risk management, increasing excitement over cell and gene therapies — and so many new things to do with antibody molecules that I could barely keep track of them all. Fragments, fusions, multispecifics, and antibody–drug conjugates — it’s a veritable menagerie of modalities beyond the familiar monoclonals. Disposables are no longer “cool new gadgets,” but have become obvious options in process development and manufacturing. A number of biosimilars are on the market, especially in Europe, but patent issues are holding many at bay even after they’ve gotten regulatory approval. High-throughput and automation technologies have changed upstream and downstream process development — not to mention laboratory work. Everyone is talking about information technologies and the possibility of making traditional batch processing continuous.
A quick perusal of our most-downloaded articles of the past decade reveals that BPI readers remain keen on some perennial topics: bioassays and product stability, viral safety and host-cell impurities, and improving the performance of upstream and downstream processes. But two underlying themes are speed and cost. I see those as pointing the way to what is likely to characterize the 2020s: a holistic and strategic approach to solving problems in the industry.
Our authors, readers, and conference presenters all seem to understand — more now than ever — that decisions made at one phase of development or in one stage of biomanufacturing will have ripple effects throughout a business and its operations. Saving time in one process might make another more complicated, and saving money early on might cost more in the long run. But it’s also true that one group can help another by including the other’s concerns in decision making. Information is key — and sharing it in the best possible way will make all the difference. Where will this new mindset take the industry beyond 2020? Watch this space.
