Several smaller-market countries in the Asia–Pacific region are looking to biotechnology as a significant driver for their economic growth. Some present themselves as wide open to foreign investment, hoping to attract partners or contract clients from overseas. Others are working to develop homegrown industry through local research and financing. A few have banded together in an Asian “light†version of the European Union. ASEAN Countries The Association of Southeast Asian Nations (ASEAN) is a geopolitical and economic organization of 10…
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Effect of China’s Talent Scheme on Life-Science Innovation
The impact that the migration of talent is having on life sciences companies’ ability to innovate and differentiate themselves worldwide is a topic of constant concern. Of particular interest are the increasing flows between the United States and China. China’s “1,000 Talents Scheme†and similar initiatives at the local level were specifically designed to help the country become a world leader in innovation. Such programs incentivize people who are among the top 10 practitioners in their field to return to…
China Ranked Top Potential Biopharma Outsourcing Destination
Until recently, China had not been considered a global contender for outsourced biopharmaceutical manufacturing. In fact, it’s been less than a decade since pharmaceutical contract manufacturing in China became legal (1). Yet, the industry now ranks China as the most likely biomanufacturing outsourcing location. According to our recently released study, 17% of the industry considers China as the top future offshore production destination (Figure 1). The BioPlan 2011 Eighth Annual Report and Survey of Biomanufacturing Capacity and Production shows China…
Top 10 Changes in FDA’s Process Validation Guidance
Two years after drafting a comprehensive revision of the 1987 process validation guidance, the FDA finalized the document this year. The revision elaborates on modern quality by design (QbD) techniques for developing a process, analyzing risks, and monitoring for control. The initial draft update remains largely intact, with some important adjustments focused on clarifying the FDA’s intent for how the industry is expected to validate its processes. 1 — Minor Changes: The guidance includes more references to the Code of…
Disposable Downstream Processing for Clinical Manufacturing
Although disposable parts and modules have been used in the biopharmaceutical industry since the 1970s, as detailed in the “History†box, total disposable manufacturing has become a viable option only very recently. Whereas liquid storage became disposable in the 1990s, processing operations such as depth filtration, tangential-flow filtration (TFF), and chromatography have still required skids with reusable flow paths that needed cleaning and sanitization. Important recent milestones in total disposable technology included introduction of stirred bioreactors by HyClone (Thermo Scientific)…
Quality By Design and the New Process Validation Guidance
Where were you in 1987, and what were you doing? I’m not too embarrassed to say that I was beginning my last year of high school and paying far more attention to guitar lessons and writing my first novel than what I might eventually do for a career. Meanwhile, the US FDA was publishing a guidance document on process validation that the biopharmaceutical industry has relied on ever since. I’m willing to bet that quite a few readers…
The New US Biosimilar Legislation, One Year Later
About a year ago, President Obama signed into law the highly publicized health care reform bill known as the Patient Protection and Affordable Care Act. This legislation included the new Biologics Price Competition and Innovation Act of 2009 (now a “biosimilar statuteâ€). Before enactment of that biosimilar statute on 23 March 2010, no “abbreviated†regulatory approval system existed in the United States for biologics — unlike Europe, which has had a system since 2005, and unlike US generic…
Won’t Get Fooled Again
The world loves a winner, and no one wants to be linked to a failed endeavor that could stall or otherwise negatively affect his or her career. If you’re reading this magazine, you’ve probably been inspected or audited by regulators and/or customers at some point. When it was finished, did your company compare favorably with expectations, or did the reports reflect a negative image? Did they mirror management’s view of operations, or was there a disconnect with management…
Are Single-Use Technologies Changing the Game?
Recently, I have heard the term game changer used to describe single-use technologies (SUTs). Whether this is hyperbole or reality remains to be seen. But it does bring baseball to my mind. After all, it’s finally spring, games began in April, and optimism reigns supreme — at least in some major-league cities. I was struck recently by an article in my home-town Washington Post by venerated columnist Thomas Boswell, who wrote in March about hope for the future of our…
Productivity Bottlenecks Drive the Demand for Innovation
Spending is up, the global economy is slowly getting back on track, and the biopharmaceutical industry continues to roll along at double-digit growth. Productivity has been the primary industry focus over the past few years, and it remains a hot topic. Companies are aggressively going after the bottlenecks to their efficiency, and now they’re opening their wallets to fix what’s broken. One of the biggest productivity fixes today centers on improved single-use devices and systems. They top a…