DOWNSTREAM PROCESSING FEATURED ARTICLES
Recently, the U.S. Food and Drug Administration issued a proposal designed to assist companies developing new treatments for patients in the early stages of Alzheimer’s disease, before the onset of noticeable (overt) dementia.
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NIH Scientists Map First Steps In Flu Antibody Development
National Institutes of Health scientists have identified how a kind of immature immune cell responds to a part of influenza virus and have traced the path those cells take to generate antibodies that can neutralize a wide range of influenza virus strains. Study researchers from the National Institute of Allergy and Infectious Diseases (NIAID), part of NIH, were led by Gary Nabel, M.D., Ph.D., director of NIAID's Vaccine Research Center. Their findings appear online in advance of print in Nature.
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How Can You Mitigate The Risks Of Single-Use Bags?
The loss of product as a result of bag failure isn’t just an annoyance; it’s an expense, and a costly one at that. However, Chuck Hart, director of manufacturing at Prolong Pharmaceuticals, says with proper fitting and handling, these concerns can be mitigated.
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Crucell And Scripps Research Discover And Describe Broad-Spectrum Antibodies Against Influenza B, A Crucial Link In Development Of Universal Flu Therapies And Vaccine
In a landmark discovery, researchers from Crucell Holland B.V. and The Scripps Research Institute, recently announced the identification of the first human monoclonal antibodies that appear capable of disabling all influenza B viruses.
DOWNSTREAM PROCESSING WHITE PAPERS & CASE STUDIES
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Optimized Sterile Filtration of Pharmaceutical Solutions
The cost of filtration and separation stages within the production of pharmaceuticals has been increasing along with the increased complexity of final drug products.
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Automating Protein Purification Processes Achieves Reliable Results And Reproducibility
ÄKTA start is an easy-to-use, reliable protein purification system. In this application note it is described how Erica, a post-doctoral researcher, used ÄKTA start to purify GST-tagged protein using a predefined method template, a GSTrap FF column, and a Frac30 fraction collector.
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Microbial Fermentation In Single-Use Xcellerex™ XDR-50 MO Fermentor System
This application note describes the performance of a single-use Xcellerex XDR-50 bioreactor system when used in cultivations of E. coli and of modified Pseudomonas fluorecsens (P. fluorescens) producing a monoclonal antibody (MAb). Both the achieved microbe densities and product yield were shown to be consistent with the performance of conventional stainless steel systems.
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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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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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An Automated Profiling Application For G9a Histone Methyltransferase And Bromodomain Proteins
Due to several findings, G9a and BET bromodomain proteins have become the target for numberous drug discovery projects. In this study, we describe a novel, cell-based assay platform that uses the robust, yet simple Enzyme Fragment Complementation (EFC) Technology.