One response to a survey we sent out last year kept coming back to me as we prepared this issue. In answer to what a company does if a product in development doesn't fit into the company's platform technology, one answer was, “We innovate a solution.” Whether meant seriously or not, it rings true to the history of the industry's ability to invent and reinvent solutions as necessitated by economic realities.

When we began working on the topic of this special issue, we thought we knew the trends and would simply be offering examples of the burgeoning of “local” manufacturing around the world. We assumed that the global biotech industry had reached a sort of geographical “tipping point,” when in actuality, the choices appear to be much less clear-cut. It is true that what has in the past been accomplished by vertically integrated companies in major biotech hubs can now be done pretty much anywhere in the world. This presents companies, new and established, with a number of business models and options — but not yet a lot of cumulative experience doing business in a number of regions that are now aiming to attract the industry. We realized we needed to explore not only what those options are (or rather, how they come together), but how it is that companies sift through available technologies and related business options in the first place.

Another component of this puzzle is provided by a general theme that we noticed at the recent BIO convention, especially as I listened to the presentations in BPI's BioProcess Theater there. Seldom have I seen so many new approaches being advanced all at once, and in such combinations, challenging even our assumptions of what biotherapeutics/pharmaceuticals will be in the future. Recombinent technologies have helped give vaccines a virtual “shot in the arm”; cell and gene therapies have quietly been proceeding through clinical trials, and with the Dendreon approval charting the path, now may have a clearer path to approval and commercialization. Combination (or convergence) therapies and personalized medicines are creating new regulatory conundrums as devices and diagnostics merge with therapeutics. And economic development groups in emerging countries see opportunities to attract business and advance their own products, with biosimilars already on the market in some regions.

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Single-Use at the Forefront: We laid the groundwork for this issue by developing a roundtable discussion at the Interphex conference this past April (see the “Interphex Roundtable” box). Our speakers highlighted critical elements behind manufacturing and distribution options, pandemic preparedness, and economic realities. And yet, when the time for Q&A came around, all the questions had to do with the scalability of single-use technologies. These technologies have certainly been a “disruptive” influence on the industry, but they are not alone in paving the way for local manufacturing.

Local?

So, first, a definition: Local, in this issue, can refer to

• In-house, nonoutsourced production and/or manufacturing (and the extent to which companies are able to keep some work in-house that may have been outsourced in the past)

• Production and/or manufacturing in the specific region of eventual distribution, either as a self-contained company or as a remote subsidiary of a company headquartered in another country.

If it is “local,” it is under your control. If you intend to market to the world, and you have an established manufacturing center in your home country, then your current distribution channels may be the best choice. If by contrast you are making a therapeutic vaccine or other biotech drug for a disease or illness specific to a remote region, it may make little economic sense to produce it in, say, New Jersey — especially given potential supply interruptions in cases of political crises or outbreaks of disease.

In between those two extremes are any number of combinations of approaches — and viewpoints. And entering the field in increasing numbers are companies and agencies in the so-called developing world, advancing their own innovations and working to become global manufacturing hubs in their own right and seeking to supply their own regions with the raw materials of drug development.

Our goal in this issue is to provide a combination of anecdotal and documented viewpoints to create a clearer picture of where the industry might be headed — and what elements are still needed to “tip” biopharmaceutical manufacturing into a truly global manufacturing arena.