DOWNSTREAM PROCESSING FEATURED ARTICLES
America’s biopharmaceutical research companies are testing 981 medicines and vaccines to fight the many types of canceraffecting millions of patients worldwide, according to a report released today by the Pharmaceutical Research and Manufacturers of America (PhRMA).
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Pathobiology Professor's Vaccine Platform Gives Immune Systems A Boost
Dr. Bernhard Kaltenboeck, professor of pathobiology in Auburn University’s College of Veterinary Medicine, and research associates Erfan Chowdhury and Yihang Li have developed a vaccine platform to treat intracellular diseases for which antibodies are ineffective.
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FDA Reports Conditions Observed At New England Compounding Center Facility
Recently, the U.S. Food and Drug Administration released a copy of the FDA Form 483 issued to the New England Compounding Center (NECC). The FDA observed and has since confirmed contaminated products and listed a number of observations regarding conditions in the clean room at NECC’s Framingham, Mass. facility.
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Saint-Gobain Introduces Sani-Tech® Ultra
Saint-Gobain Performance Plastics continues its long tradition of innovation in ultra-pure tubing technology with new Sani-Tech® Ultra. This platinum-cured silicone tubing meets the stringent requirements of demanding biopharmaceutical process applications while delivering improved performance in a number of areas.
DOWNSTREAM PROCESSING WHITE PAPERS & CASE STUDIES
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Met One Sensors Resistant To Vaporous Hydrogen Peroxide (VHP) Pharmaceutical manufacturers often require an aseptic production environment to minimize the presence of microbes and their potential contamination of the manufactured product.
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Proven Long Life Lasers™ In Optical Particle Counters Optical particle counters (OPC) utilize light illumination and extinction to determine the presence, size, number and/or concentration of particles. Particles are typically suspended in a fluid or air, which flow through the volume that is illuminated and viewed by the detection system.
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Monoclonal Antibody Purification Platform Using High-Capacity Protein A And Mixed-Mode Chromatography
The first step in purification of an important class of therapeutic proteins, the polyclonal or monoclonal antibodies (mAbs), is their capture from plasma or tissue culture supernatants. Protein A–based media are by far the most common class of affinity products used for this purpose.
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Turning Data Into Information
As biopharmaceutical manufacturing has evolved from small-scale lab production in small flasks to massive commercial production in deep-tank bioreactors, an avalanche of production data has evolved to support it. From individual unit operation skids to distributed control systems and enterprise resource planning tools, biomanufacturing today is buried by the sheer quantity of data coming in from the manufacturing floor.
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Single-Use Connections Advance Aseptic Processing
John Boehm discusses how single-use connections advance aseptic processing and create increased process flexibility and reliability while reducing costs.
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Metal Removal From Fine Chemical Products
Metal contamination in various injectable or even oral medicines is a serious concern.