Most people in the biopharmaceutical industry recognize, at least anecdotally, that the use of disposables in biomanufacturing is moving forward. At BioPlan Associates, we’ve tried to quantify how things are advancing and capture some of the shifts in attitudes, especially in light of current economic challenges. The major shift is that decisions are being made more from an operational point of view. It’s become less a question of if disposables will be implemented than of where and how.…
Business
Ratiometric Photometry Improves Laboratory Quality Assurance
Laboratory scientists often assume that their liquid-handling instruments, from pipettes to automated liquid handlers, are operating within specification. But given that data integrity for applications from drug discovery to molecular diagnostics relies on accurate and precise liquid delivery, that can be a very risky assumption with high costs of failure. Those costs and risks are compounded by several trends in today’s life-science laboratories, such as the growing use of valuable reagents at low volumes and an increasingly strict regulatory environment.…
Encyclopedia of Rapid Microbiological Methods
Many different rapid microbiological methods (RMM) have been developed in recent years, although their acceptance and implementation in the pharmaceutical industry has been slow. To stimulate the integration of RMMs in the pharmaceutical industry, the Food and Drug Administration (FDA) introduced the Process Analytical Technology (PAT) initiative in 2004. A year later, the Encyclopedia of Rapid Microbiological Methods, edited by Michael J. Miller, was published. Miller, senior research fellow in the manufacturing and science department at Eli Lily, recruited many…
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…
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…
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…
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…
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…
Growing the Future
No segment of the biotechnology industry has received more public scrutiny than agricultural biotech — except maybe its application to food. And none has been subject to more “hype†and high hopes for instant results than biofuels. By contrast, industrial biotechnology seems almost invisible to the public at large. In general, the more immediate the effects on consumers, the more likely they are to pay attention and either laud or loathe the associated technology. The general public…
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…