As the biopharmaceutical industry in China continues to grow, the corresponding demand for high-quality, tactical information and proven strategies continues to increase. Although many people see China’s current technologies and skillsets as lagging behind those of more advanced counterparts in North America, Europe, and Asia, the Chinese industry’s thirst for knowledge and eagerness to adopt and adapt new techniques have enabled it to leap-frog development at an astonishing speed. At IBC’s fourth annual BioProcess International China event, the goal is…
2012
A Decade of Filtration
Filtration is just as vital to bioprocessing as chromatography — and arguably even more so. Filters are not only used as downstream unit operations in themselves, but also in support of nearly every other step in bioprocessing. Gas or liquid filters ensure the quality of incoming air and feeds for cell culture operations, clean the circulating media in perfusion processes, aid in harvest clarification, and remove buffers from chromatographic eluate after chromatography columns. They are used in formulation…
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 Process Development
Our “manufacturing †theme could be considered a sort of catch-all, encompassing much of what BioProcess International covers. You could argue that “the whole development process†is all about manufacturing biotherapeutics. But we instead consider this “pillar†of bioprocessing to include everything that isn’t strictly “upstream†(production) or “downstream†(processing) of biomolecules. Facility and supply-chain isssues come into play here, as do formulation and fill–finish (and of course, outsourcing). We discuss quality systems and their associated analytics in…
A Decade of Formulation
Although no biopharmaceutical pills are yet on the horizon, formulation and delivery have advanced over the past 10 years. Formulators have new biophysical technologies and new product types (such as protein–drug conjugates) to work with. The most important issues haven’t changed much, though — from aggregation to stability, freezing to freeze-drying — although the FDA’s quality by design (QbD) initiative changes the strategies used to address them. Fragile proteins and other biologically sourced macromolecules need protection to achieve…
A Decade of Fill–Finish and Packaging Solutions
In 2003, BPI’s first year of publication, the Food and Drug Administration released a draft of its updated guidelines on aseptic processing. In it, the agency included the statement, “A well-designed positive pressure isolator, supported by adequate procedures for its maintenance, monitoring, and control offers tangible advantages over classical aseptic processing, including fewer opportunities for microbial contamination during processing†(1).That kind of statement, seemingly approving one technology over another, was unprecedented in an FDA guidance and perhaps an…
A Decade of Characterization
Over the past 10 years, the biopharmaceutical industry has placed increasing pressure on analytical laboratories, whose work is more important to the success of biotherapeutic products than ever before. Nearly concomitant with the appearance of BPI on the scene, the US Food and Drug Administration put forth its final report on the 21st century good manufacturing practice initiative, which in changing how regulators would review product applications, changed how companies must approach them (1). The guiding principles —…
A Decade of Change
Allen Roses, former worldwide vice president for genetics research and pharmacogenetics at GlaxoSmithKline, raised eyebrows in 2003 when the newspaper The Independent quoted him as saying that the vast majority of drugs — more than 90% — work in only 30 or 50% of the people. “I wouldn’t say that most drugs don’t work,” he said. “I would say that most drugs work in 30 to 50 percent of people.” Though the newspaper characterized this as an “open secret within…
A Decade of Biomanufacturing
The biopharmaceutical industry is emerging from four years of economic challenge in a very healthy state. Process improvements over the past decade have played a major role in keeping the industry healthy. Earlier this decade, most companies were more concerned about quickly getting their drug products to market than about strategically controlling costs of operations. But according to my group’s recent study, this has changed in most areas of manufacturing. In fact, although this year companies reported overall…
A Decade of Product Development
In 2004, the United States Food and Drug Administration (FDA) transferred regulation of many highly purified, “well-characterized†biopharmaceutical proteins from the Center for Biologics Evaluation and Research (CBER) to the Center for Drug Evaluation and Research (CDER), which until then had primarily regulated only synthetic, small-molecule drugs and chemical substances. The most novel/complex and the less-characterized biologics remained within CBER’s jurisdiction. This change complicated BPI’s mission somewhat. When the magazine was founded, we responded to questions from advertisers…