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…
Business
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…
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…
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 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…
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…
Why Do So Many Biopharmaceuticals Fail?
Biopharmaceutials and the processes used to make them are exceedingly complex, and the path to developing new therapeutics is a high-risk endeavor. The emphasis today is on controlling product quality, safety, and efficacy through understanding biological mechanisms, key product attributes, and process parameters. Such information is also crucial for guiding development efforts to improve chances of success in the clinic and for gaining regulatory approval. Analytical methods provide the foundation for acquiring such knowledge. Efforts devoted to developing meaningful and…
2008 in Review
As the Chinese calendar warned us, it did indeed turn out to be a year of the rat. If you‘re in any doubt about the economic crisis of 2008, here’s a single significant indicator: Pharmaceutical companies’ spending on advertising declined this year for the first time in history. Walgreen’s CEO Jeffrey Rein was quoted in FierceBiotech as calling 2008 “the tightest market for prescription drugs” in his 27-year career. If big pharma and big retail were feeling the pain, of…
Partnering with a CMO in China
Many biopharmaceutical companies are evaluating the option of working with contract manufacturing organizations (CMOs) in China. There are probably as many reasons for following that strategy as there are companies doing the evaluating. However, regardless of the strategic plan behind pursuit of a CMO in China, there are key issues each company must consider as part of its due diligence before selecting one. Through a fast growing economy and government supported transition from low-margin to high-margin products, China is quickly…
Puerto Rico Aims to Be the Biotech Island
Our vision is to be the preferred partner for industry and academia for biotech training, research, and development in the American hemisphere by 2012.” That’s the vision statement of the Bioprocess Development and Training Complex (BDTC) in Mayaguez, Puerto Rico, which opened 11 September 2008. The BDTC is the latest in a series of developments designed to make Puerto Rico “Bio Island,” the goal of Governor Anibal Acevedo-Vila. As he described in a conversation with BPI at the 2008 BIO…