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Single-Use Mixing Technology for Virus Clearance (Part 2: Compatibility, Leachables, and Scale-Up Studies)The second half of this article describes the testing methods used by the authors to demonstrate the applicability of single-use mixing technology for virus inactivation.
Latest:
Single-Use Mixing Technology for Virus Clearance (Part 2: Compatibility, Leachables, and Scale-Up Studies)The second half of this article describes the testing methods used by the authors to demonstrate the applicability of single-use mixing technology for virus inactivation.
Latest:
Single-Use Mixing Technology for Virus Clearance (Part 2: Compatibility, Leachables, and Scale-Up Studies)The second half of this article describes the testing methods used by the authors to demonstrate the applicability of single-use mixing technology for virus inactivation.
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Can QRM Transform Biopharmaceutical Operational and Quality Culture Excellence?Applied throughout a product’s lifecycle and across a company’s portfolio, quality risk management and knowledge management will enable more agile manufacturing and better quality standards in the future.
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Using Nondestructive in-situ Measurements to Ensure Lyophilized Product StabilityNon-destructive surface area measurement can improve stability testing.
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Methods Accelerate Biosimilar AnalysisEffective application of mass-spectrometry tools can optimize biosimilar analysis, reducing development time and cost.
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Using Multiple Techniques in Biosimilar AnalysisApplication of multiple techniques at different conditions presents a more complete picture of a dynamic situation.
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The Use of Analytics in Biopharmaceuticals: An IntroductionThis article provides an overview and introduction to the use of analytics in biopharmaceutical development and manufacturing.
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Industry Outlook 2025: European Geopolitical Impact on PharmaBioPharm International® spoke with Alexander Seyf, CEO and co-founder of Autolomous, about the impact geopolitical changes in Europe might have on the bio/pharmaceutical industry.
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Sponsor-CMO Conflict Management for Clinical-Phase BiologicsThe authors present the CMO's perspective on various potential sources of sponsor-CMO conflicts.
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High Throughput Phage Display for Accelerated Antibody Drug DiscoveryBio-Rad Laboratories, Inc., Pioneer™ Antibody Discovery Platform helps streamline the phage display-based discovery process and provides researchers with superior identification of high-quality therapeutic antibodies.
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Separation and Purification of a Tissue-Type Plasminogen Activator from Trichoderma reeseiThis research proposes a method for separating and purifying tissue-type plasminogen activator from a fungal cell source.
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Separation and Purification of a Tissue-Type Plasminogen Activator from Trichoderma reeseiThis research proposes a method for separating and purifying tissue-type plasminogen activator from a fungal cell source.
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Separation and Purification of a Tissue-Type Plasminogen Activator from Trichoderma reeseiThis research proposes a method for separating and purifying tissue-type plasminogen activator from a fungal cell source.
Latest:
Separation and Purification of a Tissue-Type Plasminogen Activator from Trichoderma reeseiThis research proposes a method for separating and purifying tissue-type plasminogen activator from a fungal cell source.
Latest:
Separation and Purification of a Tissue-Type Plasminogen Activator from Trichoderma reeseiThis research proposes a method for separating and purifying tissue-type plasminogen activator from a fungal cell source.
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Unprocessed Bulk Testing for BiopharmaceuticalsUnprocessed bulk material harvested directly from the bioreactor should be tested for contamination prior to downstream processing.
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Comparing Facility Layout Options for Managing Business and Operating RisksThe authors present a risk analysis of the impact of various business and operating risks on three facility layout strategies.
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Simulating Reality in Mock InspectionsMock inspections-if conducted properly-can prepare a pharma company for the day FDA knocks on the door.
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NIST Fluorescence-Based Measurement ServicesFluorescence has long been used to detect biological targets. As these measurements are becoming more and more quantitative, standards are needed to ensure accuracy and reproducibility.
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NIST Fluorescence-Based Measurement ServicesFluorescence has long been used to detect biological targets. As these measurements are becoming more and more quantitative, standards are needed to ensure accuracy and reproducibility.
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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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Biopharmaceutical Manufacturing Using Blow–Fill–Seal TechnologyThe authors give special consideration factors affecting blow–fill–seal technology.
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Modeling the Degradation of mAb TherapeuticsKinetic models can be used to study aggregation and fragmentation to help ensure stability.
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Efficacy of a Simple Static Cleaning Procedure for SPTFFA key technology that can help achieve a continuous production flow is single-pass tangential flow filtration.
