DOWNSTREAM PROCESSING FEATURED ARTICLES
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) for its IgG Antibody to herpes simplex virus (HSV) types 1 and 2 assays for use on cobas® modular platforms. The tests are intended for use with sexually active individuals and expectant mothers as an aid in the presumptive diagnosis of HSV-1 and HSV-2 infection.
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High-Flow Sterile Connectors For Single-Use Applications
Over the past decade, two developments have increased demand for high fl ow-rate connectors: Size advances in single-use bioreactors up to 2000L and the implementation of single-use downstream.
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BioChip May Make Diagnosis Of Leukemia And HIV Faster, Cheaper
Inexpensive, portable devices that can rapidly screen cells for leukemia or HIV may soon be possible thanks to a chip that can produce three-dimensional focusing of a stream of cells, according to researchers.
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Diabetes Research Reveals Important Link To Overcoming 'Lazy Insulin Granules'
Scientists at Toronto Western Research Institute have made an important discovery on the role of a SNARE protein known as VAMP8 in the release of insulin from the pancreatic islet beta cells.
DOWNSTREAM PROCESSING WHITE PAPERS & CASE STUDIES
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Cultivation Of Human CAP Cells: Evaluation Of Scale-Down Capabilities
The following application note illustrates how the DASbox Mini Bioreactor System combined with the BioBLU 0.3c single-use vessels supports bioprocess development in human cell culture.
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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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Important Considerations For Implementing A Single-Use Biomanufacturing Strategy
Recent trends in biomanufacturing technology and the biopharmaceutical market are supporting the increased adoption of single-use (SU) manufacturing systems. On the demand-side, the biopharma industry is focusing on niche and rare diseases with smaller patient populations, resulting in the need for smaller, more agile biomanufacturing capacity. By Jodi M. Zobrist and Nicole W. O'Brien, Ph. D., Gallus Biopharmaceuticals, LLC
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The Challenge of Measuring Total Organic Carbon In Modern Pharmaceutical Water Systems
Total Organic Carbon (TOC) is one of the quality attributes defined in the European and USA pharmacopoeias for pharmaceutical waters. Modern water treatment systems can deliver such high purity water that TOC levels can be consistently close to zero and very difficult to measure with any accuracy. This paper discusses some of the challenges when using TOC analysers to demonstrate pharmacopoeial TOC level compliance for modern water systems in the light of the ICH Q2 document from the International Conference on Harmonisation.
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Biomanufacturing Flexibility
This white paper from BIO-G looks at how to create flexible, agile manufacturing facilities to respond to the current glut of biomanufacturing capacity and industry consolidation. Future proofing these facilities for higher titers and multiple product lines is also explored.
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Selecting The Optimal Resins For Endotoxin Depletion In Process Purification
A guide to effectively remove endotoxins with versatile process resins.