March 2009

Global Marketplace

Point-of-Use Filtration Product: SFE filter cartridges with -222 O-ring adapters Application: Small-batch processing of liquids and gases Features: New high-performance, small-flow–element filter cartridges with optional -222 O-ring adapters come in 2.5-in. (6.4-cm) or 5-in. (12.7-cm) lengths. They are designed for point-of-use filtration and small-batch processing of liquids and gases with flow requirements 10 log reduction of Acholoplasma laidlawii at 107 cfu per mL. Laser barcodes simplify data capture. The filters are available in sheet, cartridge, and capsule formats. Contact Pall…

The Human Network

      Biotechnology is not simply about science or technology, process engineering or cell lines, corporations or regulations. It’s ultimately about the people involved in all these things — and about the people they hope to serve with their biotech aspirations. It’s about scientists and technicians, businessmen and medical professionals, patients and consumers, farmers and governments, all their lives touched in one way or another by the biotechnology industry — some admittedly more than others. Policy decisions made by…

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,…

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…

Selection and Oversight of Domestic and International CMOs

Contract manufacturing is essential for early development of products by companies of all sizes, and it plays an important role in later production and testing. Product development is a complex process requiring manufacturing, optimization, and testing of candidate drugs, devices, combination products, and biologicals even before they ever reach the clinic. Contract manufacturing organizations (CMOs) provide services ranging from early product development and lead-candidate screening to process development, product manufacture, and testing. Outsourcing of development, manufacturing, testing, preclinical, and clinical…

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…

A Prescriptive Approach to Management of Solid Waste from Single-Use Systems

    In biopharmaceutical manufacturing, the disposal of solid waste from single-use systems is becoming an increasingly important issue. The new focus is driven by several major factors including a broadening range of disposable technologies enabling, in some cases, the installation of completely disposable multistage systems; improved scalability of single-use components offering production capacities to thousands of liters; and the environmental impact of waste disposal. The latter concern includes not only regulatory and cost constraints, but also the need for…