Authors
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BioPartnering: Global BioPartnering: A Personal PerspectiveBiotechnology players are emerging in countries that historically have not been substantially active in this industry.
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Definition of a Security Value Determined by Limulus Amebocyte Lysate Assay Targeting the Recombinant Human Epidermal Growth FactorThe correlation between limulus amebocyte lysate (LAL) assay and rabbit pyrogen test (RPT) targeting recombinant human epidermal growth factor (rhEGF) as active molecule was assessed.
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The Overlooked Benefits of Single-Use Technology: Improved Quality and Increased Patient SafetyReduced carryover risk and close attention to particulate control result in greater patient safety through the use of single-use systems.
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Growth Kinetics of Human Mesenchymal Stem Cells in a 3-L Single-Use, Stirred-Tank BioreactorThe authors describe the growth characteristics of human mesenchymal stem cells cultured in a stirred-tank bioreactor.
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Misconceptions of Maintenance and Reliability: A Biopharmaceutical Industry Survival GuideThe authors provide common misconceptions and key concepts behind reliability engineering.
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ZFN Technology Advances Biopharmaceutical ManufacturingApplications of ZFN technology in biopharmaceutical cell-line engineering.
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Polishing Complex Therapeutic ProteinsA new downstream purification platform using a salt-tolerant membrane adsorber.
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Increasing Capacity Utilization in Protein A ChromatographyA twin-column periodic countercurrent capture process that combines an efficient sequential, countercurrent loading process with a minimal twin-column hardware configuration is described.
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Aligning Manufacturing and Business Strategies with Single-Use SystemsThe authors explain why Catalent decided to transition from stainless steel to single-use systems.
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Polishing Complex Therapeutic ProteinsA new downstream purification platform using a salt-tolerant membrane adsorber.
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The Human Side of PartnershipsHe potential for frustration, time-wasting, and bad feelings between pharma and biotech partners is enormous. That some successful decisions are made under these circumstances is something of a miracle.
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Aligning Manufacturing and Business Strategies with Single-Use SystemsThe authors explain why Catalent decided to transition from stainless steel to single-use systems.
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When the Process Becomes the Product: Single-Use Technology and the Next Biomanufacturing ParadigmThe move to single-use manufacturing has prompted a paradigm shift in facility design.
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A Decade (and 1/2) of DealsMore than half the deals made by pharma are with companies based in the US, 28 percent in Europe, and 15 percent Japan.
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A Generic Growth Test Method for Improving Quality Control of Disposables in Industrial Cell CultureQuality control for disposable-bags
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Growth Kinetics of Human Mesenchymal Stem Cells in a 3-L Single-Use, Stirred-Tank BioreactorThe authors describe the growth characteristics of human mesenchymal stem cells cultured in a stirred-tank bioreactor.
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An Integrated Prefilled Syringe Platform Approach for Vaccine DevelopmentAn integrated focus on product design, development, operation, and control.
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A Generic Growth Test Method for Improving Quality Control of Disposables in Industrial Cell CultureQuality control for disposable-bags
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2020 Bio/Pharma Virtual Congress*** Live: Wednesday, November 11, 2020 | 8:30 AM EDT – 4:00 PM EDT *** 2020 Bio/Pharma Virtual Congress: Join Pharmaceutical Technology® and BioPharm International® for this online event that will explore the latest developments in formulation, manufacturing, and innovative drug dosage forms, as well as detailed discussions about crucial topics impacting the industry. ***On demand available after final airing until 11/11/2021***
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Identification and Quantification of Trace-Level Protein ImpuritiesA simple, sensitive, and universal platform for identification and quantification of trace-level protein impurities in biotherapeutics is described.
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Aggregation of Monoclonal Antibody Products: Formation and RemovalAggregate formation is influenced by multiple aspects of the bioproduction process but can be mitigated by good process design and control.
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Standards-Setting Activities on ImpuritiesUSP's focus in 2013 involves standards relating to organic impurities, measurement of residual DNA and host-cell proteins in biotechnology products, and elemental impurities.
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Standards-Setting Activities on ImpuritiesUSP's focus in 2013 involves standards relating to organic impurities, measurement of residual DNA and host-cell proteins in biotechnology products, and elemental impurities.
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Kinetic Analysis of Antibodies from Different Cultured MediaAn analytical method assesses the effects of media condition on cultured antibodies.
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Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and BetterTraditional project decision-making vs. a QbD approach.
