From The Editor February 2012

One disadvantage of having covered this industry for so long is that we can get too used to terminology that is no longer quite adequate. This emerged in discussions with our advisors and readers throughout the creation of our anniversary awards program. For want of other available terms, BPI has (from the start) rotated issue themes of upstream, downstream, and “manufacturing” — that third category or “pillar” that encompasses filling and finishing and activities that occur throughout process and product development specific to quality systems and overall compliance.

But does that still work? Our take is that no matter how much some distinctions change/merge/blend, what happens upstream is still different from what happens downstream. That is, product is made before it is cleaned up and processed. Although manufacturing would seem to cover the entire bioprocess (distinct from bioprocessing), any other terms we’ve thought of seem to limit that large field of activities that occur both following and during those discrete upstream and downstream processes. Production can also describe everything in one sense, but we’ve used the term in BPI specific to making the raw product upstream.

But lately I wonder whether we need to reconsider how to define the “three pillars.” Thanks to progress spurred by PAT and QbD, increased attention to comparability issues, accelerating timelines, platform development efforts (and so on), some advisors have suggested that we replace the manufacturing theme with analytics. That feels to us like more restrictive a term than we editors want, however. Also, the more we cover regenerative medicines, their up- and downstream are not exactly the same types of events as for, say, MAbs.

Not every article in every issue falls under the issue’s theme, but we try to hit that theme with a majority. That helps authors determine which issues to aim for and ensures that advertisers reach their primary client bases. But if you believe (as we do) that words can have power, do we risk misleading our readers by combining topics thematically with those that are similar but not necessarily equivalent? At what point do they reflect outdated perceptions of how things are done and potentially impede search efforts for innovative “synergies” — especially across product classes?

For this year we continue with the themes we’ve used for much of our (almost) 10 years. But we may decide to stir them up a bit in 2013. So I actively encourage feedback about what makes sense in the context of what you do for a living. How do you define/interprete those activities these days? Are you encountering difficulties in communications at this very basic level in your own research or even in communications with potential partners and investors? BPI wants to enhance your communications, not further stick to terminology that no longer works in one way or another. So please consider this one more invitation to send your comments to me at [email protected].