Author Archives: Cheryl Scott

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 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…

A Decade of Processing

    About halfway through our first decade in publication, we became well acquainted with a new buzzword phrase in the biopharmaceutical industry: downstream bottleneck (1). This followed on the heels of a manufacturing capacity crunch that had been forecast shortly before BPI made its debut. Thanks to herculean efforts by upstream process and cell-line engineers, that crunch didn’t pan out. In its place, however, high-titer production moved the pressure downstream. Now separation and purification engineers were tasked with handling…

A Decade of Chromatography: A Powerful Technology Reasserts Itself

    Chromatographic separations are vital both to the analysis of biological macromolecules and to their manufacturing. When properly applied, chromatography provides exquisite specificity in separating different molecules from solution based on their size, electrical charge, or other physicochemical properties. Large liquid chromatographic (LC) columns remove host-cell nucleic acids, endotoxins, viruses, and process intermediates from harvest material. Combine high-pressure liquid chromatography (HPLC) with mass spectrometric (MS) or ultraviolet–visible (UV–vis) spectroscopic detection, and you can qualify and quantify macromolecules in such…

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…

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…

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…