Author Archives: Cheryl Scott

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…

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…

Ten Years of Manufacturing

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 this context, as…

Ten Years of Downstream 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 concentrated…

Ten Years of Upstream Production

Disposables: Single-use technology has arguably been the biggest “story” of the past 10 years in bioprocessing. And for many people, implementation of disposable elements began soon after the turn of the century with a Wave bioreactor (1,2), first developed by Wave Biotech in 1996, now a mainstay of many an upstream process development laboratory and sold by GE Healthcare. BPI identified the significance of such technologies early on, making them the subject of a supplement in its second year. By…

Sustainability in Bioprocessing

    The concept of sustainability has evolved over the past few decades to describe conditions for harmonious coexistence of industry and nature while meeting socioeconomic requirements of present and future generations. For this environmentally focused report, I like the simple definition offered by Armstrong International, a provider of steam, air, and hot water systems that improve utility performance, lower energy consumption, and reduce environmental emissions. According to a brochure that in part describes its work with Pfizer, Armstrong defines…

Product Life-Cycle Management

    Even before the advent of biosimilar products, biopharmaceutical products faced life-cycle concerns. The discovery–development–licensure process is just the beginning. Drug sponsors hope each new product will enjoy decades of relevance and generate millions of dollars in sales. But “me-too” products will come along, process technologies will change, and patents will expire. Even product innovators have to think about comparablity. Out-of specification results can signal problems that have their roots in raw material choices and sources, equipment deviations, analytical…

Cell Culture

After over three decades of progress, cell culture bioprocesses in the biopharmaceutical industry continue to evolve. From early laboratory culture methods to vaccine production in the mid-20th century, the first biopharmaceutical companies had a century of basic understanding to build on when they developed the first recombinant expression systems. Since those first efforts in the 1980s, a succession of cell culture biologists and engineers have improved processes using a series of products that have been increasingly specified for their use.…