DOWNSTREAM PROCESSING FEATURED ARTICLES
Combination Sterile Connections For Single-Use Applications
Gain insight into why combination connections are used in single-use bioprocessing and guidance on how single-use systems can be designed to integrate the combination connectors.
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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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Frost & Sullivan: Biosimilars Market Expected To Soar
Top representatives from the healthcare industry are confirmed to attend the 2nd Biosimilars Congregation which will take place in London on the 19th and 20th of February 2013. Ranjith Gopinathan, Frost & Sullivan Program Manager for Life Sciences, Europe Practice is set to participate to the event’s Keynote Panel Discussion focusing on challenges and opportunities in the global biosimilars market.
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Boehringer Ingelheim Implements Flexible Fully Disposable Up- And Downstream Manufacturing For Biopharmaceuticals
Boehringer Ingelheim has developed and now implemented a flexible set-up and operational approach for disposable technologies within its global biopharmaceutical development and manufacturing network.
DOWNSTREAM PROCESSING WHITE PAPERS & CASE STUDIES
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Economic Analysis Of Single-Use Tangential Flow Filtration For Biopharmaceutical Applications Prior to creating an accurate economic model for TFF, a thorough understanding of the process where the TFF is used is needed. A process model is a valuable tool when properly executed and it must accurately include all critical aspects of the purification process. By Michael LaBreck, Mark Perreault, Novasep
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Automation Of A Homogeneous Proximity Assay For Detection Of Residual Protein A In Biological Therapeutics
Protein A is used in affinity chromatography for therapeutic antibody purification and has been shown to leach from columns during purification of antibodies resulting in contamination. Residual Protein A in therapeutic drugs could elicit mitogenic or immunological reactions in patients.
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White Paper: Capillary Electrophoresis — A Simple Technique
In 1989, Beckman Instruments introduced the first fully automated capillary electrophoresis instrument (P/ACE™ 2000) to the scientific community. At that time, CE demonstrated exceptional resolving of selected compounds, but the new technology lacked a track record of applications. By Beckman Coulter, Inc.
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Guidelines For Proper Filtration And Delivery Of Samples To On-Line Process Analyzers
Increasingly precise process control strategies, often linked to computer control, have accelerated the use of sophisticated on-line chemical composition analyzers in plant applications. Instruments such as gas and liquid chromatographs, ion chromatographs, laser optic instruments, atomic absorption instruments and specific ion analyzers, which were rarities in laboratories ten years ago, are now found routinely in plant settings. By Ken Perrotta, Division Engineering Manager
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Quality By Design In Biomanufacturing
QbD is increasingly required in our industry, but there are still gaps in understanding how QbD applies to the biomanufacturing process.
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Efficiencies Of Natural Convection In Passive Pallet Shippers
Bulk transportation of temperature sensitive pharmaceuticals and biologics has become a common practice due to complex global supply chains. By Iftekhar Ahmed, Ben VanderPlas, and Stu Krupnick
DOWNSTREAM PROCESSING PRODUCTS
Another proven method for cGMP processing is also available now using drums, a conical drum funnel and drum lifts.
ÄKTA avant™ is a preparative chromatography system designed for fast and secure development of scalable methods and processes.
CHT is a leading purification medium of biomolecules in today’s demanding downstream process industry. Its mixed-mode support offers unique selectivities and often separates biomolecules that appear homogeneous with other chromatographic methods. The diverse binding capabilities of CHT for host cell proteins, leached protein A, antibody dimers and aggregates, nucleic acids, and viruses allow its use at any stage from initial capture to final polishing.
DOWNSTREAM PROCESSING MULTIMEDIA
Bioprocess With The Bozenhardts is back, with a fresh episode packed with advice from Herman and Erich on the selection of filling systems for biopharmas. Listen in as the Bozenhardts give us an update on the process, logistics, and administration trends that are informing filling system decisions today, and offer direction on making choices that will prepare you for the fast-advancing therapies of tomorrow.
Bio-Rad now offers two very high capacity ion exchangers: Nuvia S, which can be used for capture and/or intermediate polishing; and Nuvia Q, which can be used for intermediate and/or final polishing.