The idea of “thinking globally, but manufacturing locally” to each market is relatively new to the biopharmaceutical industry. As I mentioned in Chapter 2, vaccine makers are more familiar with the concept already. But many technological and economic factors are making other companies aware of this option. Offshoring clinical trials has been of great interest in the pharmaceutical industry for years now. Is it more cost-effective to make clinical materials “here” and ship them “there”— or to make them where they'll be used? Can you maintain proper control over product and process, not to mention intellectual property and regulatory compliance? As with any other business strategy, these are not ventures to be taken lightly. There are pitfalls to avoid and rough waters to navigate along the way — and this kind of globalization may not be the way to go for some. For others, however, it could provide solutions to some very daunting challenges standing in the way of their success.

Recently Novozymes Biopharma's UK vice president Peter Rosholm wrote about the biopharmaceutical industry's future, pointing straight to India and China. “There will be a huge demand for biopharmaceuticals in these two economies. It's important that biopharm manufacturers continue to invest in developing countries as these will provide the best ROIs” (1). Rosholm cautioned that an increase in biogeneric competition will be concurrent, “and we will have the same trends that we see occurring in the pharmaceutical industry at the moment.” For example, Dr. Reddy's is already an international powerhouse in generic pharmaceuticals, and the Indian company is openly delving into biologics as well.

Some biosimilars will be made exclusively by new companies for their own local markets, as suggested by a deal announced in November 2009 between Malaysian companies Inno Bio Ventures and CCM Duopharma Biotech. Epoeitin will be their first product. “Our main focus is to provide affordable therapeutics to Malaysians,” commented Mohd Nazlee Kamal, group managing director of Inno Bio Ventures, at the public signing of their agreement (2). “We are glad that CCMD is also championing this cause with us.” In South Korea, meanwhile, Celltrion offers contract manufacturing services while working on its own biosimilar MAbs — and it's far from being the only Asian company putting that kind of business model to the test (3).

Home-grown biotech in some new markets may present US and European companies with attractive partnerships in lieu of building or even outsourcing to the developing world. Might licensing arrangements be a way to stave off generic competition?

Training and Expertise

One of the first questions our reviewers asked when BPI started getting article submissions from new biotech manufacturing locales was, “Is it GMP?” With most of our previous editorial experience being confined to the United States and Europe, we wondered how to present something from Tunisia, for example (4). But several made it through our peer review process just fine, and we learned a valuable lesson. It was time to recognize that the biopharmaceutical “world” was truly becoming “global.” For example, even the biennial meeting of the European Society for Animal Cell Technology (ESACT), an event you might expect to be purely European in nature, attracts presenters and attendees from all over the world.

Bioprocess engineers at Inno Biologics in Malaysia connect a flexible hose to a bioreactor in preparation for culture harvesting. (Click to enlarge)

For many years, of course, science and engineering departments at universities across the United States and Europe have welcomed brilliant students from the developing world. Consequently, biopharmaceutical companies are no strangers to non-European surnames. Just scan the author listings in any issue of BioProcess International. But something has changed in recent years: Many of these Western-educated scientists and bioprocess engineers are returning to their native countries — in particular, to India and China. Government incentives such as China's “100 Talents” program have encouraged them to return, and burgeoning biotech hubs such as Singapore, Hyderabad, and Shanghai have job openings for them to fill. Indeed, the powerful pull of family and home soil are not to be underestimated.

What this means for companies considering whether to build, buy, license, or outsource manufacturing in areas with emerging markets is that the question of bioprocess expertise and familiarity with good manufacturing practices is increasingly moot. As time goes on, that situation will inevitably continue to improve. Training and operations are less an issue of capability and more simply one of culture and communications. And companies such as Pacific Bridge (www.pacificbridge.com) are ready to provide assistance with recruitment and other issues.