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…
Friday, June 1, 2012 Daily Archives
IBC’s Fourth Annual BioProcess International China Conference and Exhibition
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…
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…
Global Marketplace
Fluid Management Product: BioFlex tubing Applications: Single-use bioprocessing Features: Meissner’s BioFlex tubing assemblies provide secure fluid paths for single-use systems and scale to allow flow rates >100 L/min. The tubing also connects disposable and stainless steel process equipment. Customizable assemblies can integrate sterilizing-grade through clarification-grade capsule filters. BioFlex products come sterile and ready to use, incorporating required tubing materials, connectors, filters, pinch clamps and other specified components. Pre- and postuse integrity testing procedures also can be accommodated. Contact…
Informatics Technologies in an Evolving R&D Landscape
Over the years, bioprocessing companies have leveraged a host of information technology (IT) to help them bring innovative new therapies to market. As the needs of a research and development (R&D) enterprise evolve, however, are such systems and applications a help or a hindrance? On one hand, the increasing sophistication of IT solutions — such as those designed to help users create advanced molecular models or track thousands of compounds through the discovery process — have enabled new…
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…
Sterilizing-Grade Filter Sizing Based on Permeability
Sterilizing filtration renders biotherapeutics free of biocontamination. In many cases, sterilizing-grade filters also reduce bioburden or facilitate closed or aseptic processing. They are used to filter active pharmaceutical ingredients (APIs), formulated bulk, cell culture media, buffer, additives, process intermediates, and so on. Such applications are often critical for ensuring a successful batch operations. Nonetheless, a significant amount of time and resources are typically not devoted to establishing filter sizing requirements for “simple†applications such as buffer filtration. Here,…
A Decade of Animal Cell Culture
Eukaryotic cells are fragile and finicky, requiring very specific culture conditions and nutrients to survive, grow, and be productive in an ex vivo environment. Even so, they have become vital to the biopharmaceutical industry’s ability to make complex biological products — overtaking yeast as a production system around 1990 and surpassing bacteria in the number of associated product approvals five years later (1). Since then, they have become even more useful, expanding their reach into the vaccine world. Mammalian cell…
Implementing a Fully Disposable MAb Manufacturing Facility
Biopharmaceutical contract services have seen some very important changes and growth in recent years, part of an increasing trend toward outsourcing by pharmaceutical companies both large and small. And we have seen a significant change in the types of services demanded by clients. In addition to typical services such as validation, analytical services, and training, for example, demand has increased for outsourcing of process development, mammalian cell culture, good manufacturing practice (GMP) production, and final formulation and filling.…
A Decade of Microbial Fermentation
Microorganisms play a vital role in modern life — with applications ranging from wine fermentation to biofuel production to solutions for complex mathematical problems (1). During the past decade, microbial fermentation for protein production reached a higher level of sophistication and wider adoption. When BPI was first published in 2003, the physical and biological characteristics of many microbial cells and the attributes of their fermentation processes were well known. Nonetheless, the economic environment at that time created immense pressure on…