Authors
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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.
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Closures for Pharmaceutical Preparations: A Review of Design and Test ConsiderationsThe author examines the use of closures for products intended for injection.
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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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Gastric-State-Controlled Bioequivalence StudiesEstablishing bioequivalence is difficult for drugs with high inter-subject variability or strong dependence on the physiological state of the gut.
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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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Optimizing Global Biopharmaceutical Operations Through Risk Mitigation and ManagementA UC Berkeley survey provides insight into biopharma's risk concerns and strategies.
