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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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Impact of ATMP Manufacturing on Process Equipment and Facility DesignAdvanced therapy medicinal products pose unique manufacturing challenges that will require appropriate and thoughtful facility design and equipment.
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Ask the Expert: Product Inspection, Part Two; Automated Product Inspection and Cold Chain ConsiderationsDirk Margosch, Vice President Visual Inspection, Assembly & Secondary Packaging at Vetter Pharma-Fertigung GmbH & Co KG, provides advice on final product inspection for small batch sizes. He also discusses how to maintain cold chain during visual inspection.
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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.
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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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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.
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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.
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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.
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Advanced Analytical Approaches for Accelerated Development of Gene Therapy ProductsDownload the White Paper and learn how detailed characterization can guide successful development of gene therapy products.
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Bioengineered Protein A Polymer Beads for High-Affinity Antibody PurificationThe authors discuss an alternative to traditional Protein A resins.
