Biotechnology truly is global, with some form of the industry in progress on every continent but Antarctica. Countries such as Brazil are even outpacing Europe and North America in the advancement of biofuels technology. But as in the developed world where this industry began, we see other countries looking first and foremost to the medical applications of biotech — because historically that’s where the money has been. Some countries are building their own fully integrated bioindustrial sectors.…
Business
Pursuing Excellence
As new medicines, vaccines, biomaterials, and biofuels move through development, companies often face some of their toughest hurdles in moving from benchtop to production-scale processes. These are not only technological, but as technology advances it becomes more difficult to find experienced talent to make use of it. Some regional endeavors, such as the National Biomanufacturing Centre in the United Kingdom and the Massachusetts Biomanufacturing Center in the United States are pooling skills and resources to help companies…
The Vaccine Renaissance
The global vaccine industry has undergone a dramatic and well publicized rebirth. Near the end of the 20th century, it faced an uncertain future with increased pricing pressures and liability challenges for marketed vaccines. Many long-standing members of the industry chose to scale back their R&D efforts or abandon them altogether. Today, however, the landscape has changed. Because of a confluence of positive factors (advancements in science and technology, greater appreciation for the role of vaccines as antibiotic resistance increased,…
An Industry in Transition
As an industry, biopharmaceutical manufacturing is in transition and is facing challenges borne out of success. It was in the early 1980s that the first products were commercialized, namely the replacement hormones insulin and human growth hormone. The industry initially grew rapidly in the early ‘80s against a background of an immature supply industry: there were no large-scale columns (>10 cm diameter), column controllers, limited resin supplies and no established ultrafiltration technology. The position today is that the industry has…
Of Mice and Men…
Few US industries demonstrate preeminent creative and financial world leadership year in and year out, but we can think of two that look forward to continuing blockbusters that will provide mountains of new cash followed by consistent follow-on revenues. In both arenas, an idea is calculated to be something that people everywhere will want, so it is launched with a huge bolus of cash and a cash burn that almost takes its company to the brink. Both industries capitalize on…
Biopharmaceutical Processes: A Glance into the 21st Century
Biopharmaceutical drug products are not only well established but also contribute to a large degree to new drug entity filings. Currently approved biopharmaceuticals and proteins are now widely used to treat diseases as diverse as cancer, autoimmune disorders, myocardial infarction and various growth factor deficiencies. The unmet medical need can be so essential, such as a novel approach to cancer treatment, that biotech companies will choose to defer the optimal design of the production process to reduce the…
Quality by Design: Current Regulatory Status and Future Challenges
Drug manufacturers face the very real challenge of being both innovative and efficient — having to get products to market quickly — whilst at the same time facing existing hurdles that can limit both of these goals. To manufacture products innovatively and quickly, while at the same time reducing costs and ensuring quality, drug manufacturers must find ways to build quality into their processes. Doing so will aid in product approvals, cut down on poor design issues and…
The Maturation of the Biomanufacturing Industry
In my opening editorial, I referred to an industry in transition. This is being driven by challenges that are by no means unique to biotech: all other industry sectors are experiencing similar pressures. We are seeing the impact in terms of factory design, manufacturing technologies, validation and business processes; these are all themes that have been addressed in this supplement. The big innovation in terms of manufacturing systems has been the wholesale acceptance of disposable manufacturing technologies during…
Defending the Supply Chain
Competition, whether commercial or military, focuses on two common objectives: making choices and converting those choices into direct action. Like commercial competition, most wars are won or lost through effective or faulty logistics. The Art of War by Sun Tzu is not merely a book about war. Captains do not carry it into battle with them. It is a book about strategy that generals and statesmen study. Mobilizing for war, committing an army to battle, and risking a power base…
The Future of US Science and Technology Policy
The United States’ global leadership in science and technology (S&T) is accompanied by a disturbing anomaly: a lack of interest in S&T issues in the country’s policy community. Although controversy has focused on specific issues (notably, embryonic stem cell research and climate change), its context has been less S&T and more about wider policy issues. The Center for Policy on Emerging Technologies (C-PET) is a nonpartisan think tank established with bipartisan support and participation from the corporate, policy, and civil…