Downstream Processing White Papers and Case Studies
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Continuous Biomanufacturing: 10 Reasons Sponsors Hesitate
The industry is abuzz with talk about continuous biomanufacturing (CB), and its virtues have been well described. Here we will look at some of the barriers or concerns perceived to limit its value to the industry. Justified or not, quite a few concerns have been expressed regarding the implementation of this new, rather disruptive technology.
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Biological Contamination Events In Isolators: What Lessons Can Be Learned?
8/17/2012
Microbiological deviation and biological contamination events have been observed in pharmaceutical isolators including those used in production, sterility test and pharmacy aseptic services. By James Drinkwater, Bioquell UK Process & Compliance Director
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Important Considerations For Implementing A Single-Use Biomanufacturing Strategy
10/18/2013
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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Comparing The Automated Pipetting To Volumetric Glassware And Air Displacement Pipettes
Analytical sample preparation is used in many industries such as forensics, environmental chemistry, mining, beer and wine fermentation and many others. Concentrated samples are diluted and analyzed via High Performance Liquid Chromatography, Gas Chromatography, Atomic Absorption, and/or Inductively Coupled Plasma Spectroscopy to name a few. Traditionally these samples are prepared using volumetric glassware, syringes and/or pipettes.
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Automated Bioluminescent ADCC Reporter Bioassay Using Bioengineered Jurkat Cells
2/10/2013
Pharmaceutical companies are increasingly exploring new biologic and biosimilar products, and thus increasing monoclonal antibody (mAb) immunotherapeutic research. By Tracy Worzella, Promega Corporation and Brad Larson, Applications Department, BioTek Instruments, Inc.
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White Paper: Economic Analysis Of Single-Use Tangential Flow Filtration For Biopharmaceutical Applications
6/10/2011
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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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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Economic Analysis Of Single-Use Tangential Flow Filtration For Biopharmaceutical Applications
6/10/2011
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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Biomanufacturing Debottlenecking And Process Optimization
3/6/2012
Optimizing biomanufacturing is particularly challenging because of variability and complexity associated with the sharing of finite and interdependent resources. By BIO-G
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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.