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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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The Challenges of Downstream Operations in the World of Continuous BiomanufacturingA continuous biomanufacturing platform can process higher/lower quantities of a drug as needed and allow manufacturers to respond to changing markets.
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Qualifying Expertise for Quality SupportBringing in external expertise may be necessary when internal knowledge is lacking, but it is critical that any contract employee or consultant is comprehensively assessed to ensure the right person is employed.
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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.
