Authors
Latest:
In-Depth Validation of Closed-Vial TechnologyThe authors describe a validation master plan for closed-vial filling technology.
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Increasing Efficiency in Protein and Cell Production by Combining Single-Use Bioreactor Technology and PerfusionAn off-the-shelf, single-use perfusion system.
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Implications of Trace Levels of Redox-Active Metals in Drug-Product FormulationThe presence of minute amounts of chelators can help minimize the degradation of monoclonal antibodies.
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Successful Wetting for Filter Integrity Testing in Volume-Restricted SystemsPall’s application note offers clear guidance for the successful wetting of filters in challenging situations where low volumes of wetting fluid must be used, such as filters on single-use systems.
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A look under the hood of LunaticLunatic pushes the rock-solid quantification technique of UV/Vis spectrophotometry to the next level of accuracy and throughput with state-of-the-art optics, precision microfluidics, honed signal processing, and purpose-built applications.
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Maximizing the Effectiveness of Upstream Bioprocessing Through the Combination of Lab Informatics and InstrumentationBy establishing effective management of data and knowledge, it will be possible to employ advances, such as artificial intelligence and synthetic biology, to their full potential in upstream bioprocessing.
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Dilution-Free Protein Concentration Measurement for High Protein Concentration SamplesAccurate protein concentration results can be obtained using standard spectrophotometers and commercially available short path length absorption cells.
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The Power to MakeAjinomoto Bio-Pharma Services is a fully integrated contract development and manufacturing organization, providing comprehensive process development services, cGMP manufacturing and drug product fill/finish services of small-molecule and biologic APIs and intermediates.
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Key Considerations When Outsourcing Cell-Culture Medium DevelopmentThe authors examine several issues that will help streamline negotiations between a service provider and a cell-culture medium consumer.
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Weighing Clinical Trial Outsourcing OptionsEvolving clinical trial research services give biopharmaceutical companies options for full and functional services.
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Plants As an Innovative and Accelerated Vaccine-Manufacturing SolutionA plant-based expression system could provide greater speed and capacity at a comparatively low cost.
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Virosomes: A Novel Strategy for Drug Delivery and TargetingVirosomes present novel drug-delivery vehicles with distinct advantages over liposomes.
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Challenges in Bulk Drug Substance Management.Final liquid drug substance production and fill–finish activities rarely occur at the same site. Nearly all pharmaceutical and biotechnology companies outsource a portion of their fill–finish needs to contract manufacturing organizations (CMOs) to help them address unexpected demand, satisfy second source policies, or better match scale with need.
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Top Tips for Successful Development of Antibody Chromatography ProcessesIn this interview, Jakob Liderfelt, Product Manager at Cytiva, discusses main challenges faced during chromatography process development for mAbs and mAb variants such as fragments and bispecific antibodies. Then, he shares his top tips for addressing challenges associated with mAb aggregates removal and separation of homo and heterodimers.
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Shaping IR Spectroscopy into a Powerful Tool for Biopharma CharacterizationsIn this peer-reviewed article, the authors present a series of experimental studies showcasing the performance of MMS in secondary-structure biopharma characterization and compare it with conventional FTIR data.
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Biopharmaceutical Manufacturing and the Power of Synthetic BiologySynthetic biology has advanced the scope and scale with which biologically derived therapeutics can be developed.
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Shaping IR Spectroscopy into a Powerful Tool for Biopharma CharacterizationsIn this peer-reviewed article, the authors present a series of experimental studies showcasing the performance of MMS in secondary-structure biopharma characterization and compare it with conventional FTIR data.
Latest:
Shaping IR Spectroscopy into a Powerful Tool for Biopharma CharacterizationsIn this peer-reviewed article, the authors present a series of experimental studies showcasing the performance of MMS in secondary-structure biopharma characterization and compare it with conventional FTIR data.
Latest:
Shaping IR Spectroscopy into a Powerful Tool for Biopharma CharacterizationsIn this peer-reviewed article, the authors present a series of experimental studies showcasing the performance of MMS in secondary-structure biopharma characterization and compare it with conventional FTIR data.
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Understanding Commercial Cell Culture Process Performance Variation Through Advanced Data AnalyticsAdvanced data analytics, including statistical modeling and machine learning technique, can enable more efficient and reliable bioprocesses.
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Understanding Commercial Cell Culture Process Performance Variation Through Advanced Data AnalyticsAdvanced data analytics, including statistical modeling and machine learning technique, can enable more efficient and reliable bioprocesses.
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Understanding Commercial Cell Culture Process Performance Variation Through Advanced Data AnalyticsAdvanced data analytics, including statistical modeling and machine learning technique, can enable more efficient and reliable bioprocesses.
Latest:
Understanding Commercial Cell Culture Process Performance Variation Through Advanced Data AnalyticsAdvanced data analytics, including statistical modeling and machine learning technique, can enable more efficient and reliable bioprocesses.
Latest:
Key Considerations When Outsourcing Cell-Culture Medium DevelopmentThe authors examine several issues that will help streamline negotiations between a service provider and a cell-culture medium consumer.
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Fermentation Process Technology Transfer for Production of a Recombinant Vaccine ComponentThe authors describe challenges faced in transfer and scale-up of a fermentation process.
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The Benefits of Combining UHPLC-UV and MS for Peptide Impurity ProfilingDetermining a peptide’s purity is challenging because impurities are often structurally similar to each other and the API and can be present at very low concentrations. New approaches offer a solution.
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Improving mAb Manufacturing Productivity by Optimizing Buffer and Media Prep Process FlowInnovative approaches, including ready-to-use materials and in-line dilution, can significantly streamline overall bioprocessing operations.
Latest:
Improving mAb Manufacturing Productivity by Optimizing Buffer and Media Prep Process FlowInnovative approaches, including ready-to-use materials and in-line dilution, can significantly streamline overall bioprocessing operations.
