Compliant companies, to paraphrase Tolstoy, are all alike. Every noncompliant company seems to find its own way to fall short of compliance with good manufacturing practice (GMP) and come, as did the writer’s famous heroine Anna Karenina, to grief. One commonality of compliant firms is that most seem to have excellent self-auditing/self-inspection programs. Indeed, many inspectors say that a primary predictor of a compliant company is a rigorous self-inspection program. Such a program is appropriately focused, adequately resourced,…
Business
A Proactive Discussion of Synthetic Biology
Experts in synthetic biology research, law, ethics, and social science from more than a dozen institutions gathered at the Woodrow Wilson International Center in Washington, DC, on 8–9 November 2010 to discuss “Societal Issues Arising from Synthetic Biology: What Lies Ahead.†The workshop was organized by the Department of Energy’s Office of Biological and Environmental Research and the Alfred P. Sloan Foundation. After plenary presentations on the first day, almost 70 participants broke into groups to discuss potential…
A Decade of Outsourcing
Outsourcing has been such an integral part of the bioprocessing industry that BPI made it the focus of its first supplement (September 2003). Since then, manufacturers continue to reach beyond local and national borders to extend their networks of partnerships to emerging markets. Global economics during the past decade have not always made outsourcing easy. Ten years ago, manufacturers faced tough decisions over whether it was more cost effective to outsource or keep process activities in-house (possibly expand…
Expansion of the Prior-User Rights Defense
A common reaction to some patents directed to manufacturing processes (especially of biotherapeutics) is “How did they get a patent for that when we’ve been doing the same thing for years?” But the number of patents covering biotherapeutic production processes is steadily increasing along with the realization that upstream and downstream processing events provide a potentially abundant source of so-called “second-generation” patent protection for biologics, especially those facing biosimilar competition. Although some groups are prolific patent filers claiming a wide…
Fight Cancer with Nanotechnology
Imagine a diagnostic test that sifts through millions of molecules in one drop of a patient’s blood to detect the tell-tale protein signature of a cancer subtype. Envision a drug “ferry†that doesn’t release its cytotoxic contents until it slips inside cancer cells — or a molecule or small panel of proteins that can reveal within days whether a cancer treatment is working. Bioprocess Applications of Nanoparticles () Researchers have created nanosized particles and devices that are…
Biopharmaceutical and Medical Device Compliance
Off-label marketing occurs when doctors prescribe a drug or device for a use that has not received FDA approval (1). Physicians have the unfettered right to prescribe the best drugs or devices for their patients, including approved drugs and devices for unapproved uses. Pharmaceutical and medical device manufacturers, however, cannot promote their products for such uses — even if those are supported in medical literature. Companies cross the line when their sales representatives sell physicians on the idea of using…
Videos Can Help Ensure Reproducibility of Scientific Results
Biological experiments must be performed correctly. A textual method description doesn’t always capture the myriad techniques involved in even a fairly simple study. So the inability of researchers to reproduce published results is becoming a problem. And it is being addressed by video methods that show exactly how scientific results are achieved, helping future researchers learn new techniques and replicate scientific results. The ability to reproduce and confirm a study’s results and conclusions is a foundation of scientific research. And…
Small–Batch-Size Production
After coexisting as close cousins in the world of life sciences, the bioprocessing and cell therapy industries now find themselves as possible allies in the pursuit of solutions to small–batch-size production technology. As cell culture titers continue to increase and biotherapies become more “personalized,†pressure is increasing on the bioprocessing industry to find more cost-effective and flexible technologies for producing smaller batch sizes than before. At the same time, the cell therapy industry (renowned for its small–batch-size production)…
Meeting Regulatory Challenges for Cell-Based Therapies
Many companies follow a general rule when assembling regulatory packages for presenting new biologics: Accentuate the aspects of your new biologic that mimic approved therapies. For companies working on cell-based therapies, however, that is a challenging task. The industry lacks established models, and the current European Medicines Agency (EMA) regulatory definition of a cell-based therapy is simply “an advanced therapy medicinal product†(ATMP) (see EMA guidance box). Regulations for cell therapies cannot always be compared directly with those…
Current Issues in Assuring Virological Safety of Biopharmaceuticals
The weakest link in the chain is also the strongest. It can break the chain.— Stanislaw Jerzy Lec, Polish writer, poet and satirist (1906–1966) Biologicals ushered in a new era for treating debilitating and life-threatening illnesses. According to a Pharmaceutical Research and Manufacturers of America (PhRMA) 2011 report, more than 900 biotech medicines and vaccines are in development that are targeting more than 100 diseases (1). Market researchers expect annual sales of biologics (now at about US$100 billion) to grow…