DOWNSTREAM PROCESSING FEATURED ARTICLES
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How To Protect High-Value Media With Single-Use Connectors
When dealing with high-value products in your downstream processes, the last thing you want is for your media to end up on the plant floor.
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COTI-2 Found To Correct Specific p53 Gene Mutation In Human Ovarian Cancer Cells
Critical Outcome Technologies Inc. (COTI) (TSX VENTURE:COT) released important new test results today proving that COTI-2, the company's lead oncology candidate, stops cancer cells from replicating by correcting the effects of specific genetic errors affecting the p53 gene.
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Combo Of Avastin, Second Drug Shows Promise Fighting Brain Cancer, Mayo Clinic Finds
The drug bevacizumab, also known by the trade name Avastin, shrinks tumors briefly in patients with an aggressive brain cancer known as glioblastoma multiforme, but then they often grow again and spread throughout the brain for reasons no one previously has understood.
DOWNSTREAM PROCESSING WHITE PAPERS & CASE STUDIES
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Managing Cell-Based Potency Assays: From Development To Lifecycle Maintenance
Characterization of a biological product — which includes the determination of physicochemical properties, biological activity, immunochemical properties, purity and impurities — is necessary to establish the safety and efficacy profile of a given product (ICH Q6B). By Dr. Weihong Wang, manager, Molecular and Cell Biology, Eurofins Lancaster Laboratories
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A Purification Strategy For Clinical-Grade Monoclonal Antibody
mAbs are currently the most important class of therapeutic proteins. Advances in upstream process technologies have led to tremendous improvement of mAb titers in mammalian cell culture.
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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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Sani-Tech® Ultra White Paper
For several years, pharmaceutical manufacturing professionals have increasingly stated concerns about material leachables and extractables and their impact on the products they produce. Fluid transfer systems that include flexible tubing have been at the forefront of this discussion.
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Metal Removal From Fine Chemical Products
Metal contamination in various injectable or even oral medicines is a serious concern.
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Avoiding Drug Shortages With Microbial Detection
Over the past year, critical drug shortages used to treat a host of life-threatening illnesses have been making headlines. Microbial contamination has been cited as a major contributor to the shortage, yet the prevailing practices to ensure the safety of drugs have been slow to change. In most cases, quality assurance practices safeguarding the drug making environment continue to rely on periodic air and a culturing method from a prior century. By Aric Meares, President and CEO, BioVigilant