Downstream Processing White Papers and Case Studies
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Agilent Microarray Grant Application Support White Paper
1/25/2012
This guide offers an overview of Agilent’s microarray and SureSelect product offerings with ordering details to assist researchers with the details of grant submission.
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Biomanufacturing Supply Chains
12/22/2011
This white paper examines the major issues with biopharmaceutical supply chains and how to balance inventory and risk optimally in the network.
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Improving DNA Removal from Bioprocess Purification Processes
Many new biological drug products produced using recombinant DNA technology, such as monoclonal antibodies, are produced in cell culture. Because therapeutic proteins such as monoclonal antibodies are produced in cell culture, impurities can result from the host cells, or cell substrates. By 3M Purification Inc.
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Cultivation Of Human CAP Cells: Evaluation Of Scale-Down Capabilities
4/18/2016
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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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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Determination Of kLa Values Of Single-Use Bioreactors
8/3/2016
Because single use bioreactors offered by manufacturers vary in parameters critical for oxygen transfer, they are often not comparable to each other and to conventional glass and stainless steel vessels.
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Mammalian Virus Purification Using Ceramic Hydroxyapatite
Conventional techniques for mammalian virus purification produce variable quality, quantity, and significant loss of particle infectivity. We propose the chromatographic separation of viral particles of diverse sizes and from different families such as dengue, influenza, mouse hepatitis, adenovirus, poliovirus using CHT Ceramic Hydroxyapatite resin.
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USP <787> Small Volume Testing With Liquid Particle Counters
By their very nature, biological therapeutics are not only expensive to manufacture but are often produced in small volumes.
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Guidelines For Proper Filtration And Delivery Of Samples To On-Line Process Analyzers
5/25/2012
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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A Purification Strategy For Clinical-Grade Monoclonal Antibody
10/3/2016
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.