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
Molecular Medicine
In the 1980s biotechnology began to transform medicine with the introduction of recombinant hormone treatments and “magic-bullet†drugs based on monoclonal antibodies. In the 1990s, protein kinases offered a key to cancer treatment, and gene therapies promised to address many diseases at their most basic, genetic level. The 21st Century has brought us stem cells, RNA interference, biomarkers, and predictive medicine. None of these things has supplanted the others; instead, they merely expand on the basic idea…
The Business of Biotech
Calivin Coolidge, who served as president of the United States from 1923 to 1929, is often misquoted as saying “The business of America is business.†According to historians, however, what he really said was, “The chief business of the American people is business.†And he went on in the same speech to say, “Of course, the accumulation of wealth cannot be justified as the chief end of existence.†So the real Coolidge (as opposed to the caricature…
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,…
Overcoming Barriers to Success
Eli Lilly’s 2001 annual report stated that “Xigris… will prove to be one of our industry’s genuine breakthroughs” (1). The company believed that its first-in-class drug “could help save one in five people who otherwise would die” from severe sepsis. One of the world’s oldest and most virulent killers, sepsis is the third most common cause of death for hospitalized patients in the developed world after heart disease and cancer. In the United States alone, 750,000 patients are hospitalized with…
A Vital Link
Clinical studies serve as a bridge between biopharmaceutical laboratories and the patients who need therapies. Drugs need to be tested in small populations before they are made available to the world at large. In a 2006 interview with BioProcess International, editorial advisor Michiel Ultee (vice president of Process Sciences for Laureate Pharma) said, “Until your product is tested in humans — and shown to be safe and to have some efficacy — then you really don’t have…
Creating an Effective Strategy for Offshoring to China
China’s business landscape offers enormous opportunity for both traditional foreign direct investments and newly hot foreign private equity (PE) and venture capital (VC) investments. The country’s economy has grown at an annual rate of nearly 9% for 25 consecutive years, and its growth is forecast to continue at an annual rate of 8% despite the current global economic crisis. Foreign investment in billions of dollars are continuing to flow into China. But the country’s explosive market growth also presents tremendous…
Automated Liquid Handlers As Sources of Error
Use of automated liquid handling equipment for rapid testing and reproducible screening of thousands of molecules, cells, and compounds has become an essential component of life-science laboratories across the globe. Along with an increase in such use, transferred volumes have shrunk, as demands increase on transfer accuracy and precision when aspirating, diluting, dispensing, mixing, and washing. Automated liquid handlers are generally used to increase the productivity and repeatability of volume transfer, but as discussed here, they are still…
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…