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Latest:
Study on an Inactivation Evaluation Method of Cleaning Processes for BiopharmaceuticalsThis study was successful in establishing a reliable and effective method for evaluating cleaning processes based on risk. Click here to view a PDF of this article.
Latest:
Study on an Inactivation Evaluation Method of Cleaning Processes for BiopharmaceuticalsThis study was successful in establishing a reliable and effective method for evaluating cleaning processes based on risk. Click here to view a PDF of this article.
Latest:
Study on an Inactivation Evaluation Method of Cleaning Processes for BiopharmaceuticalsThis study was successful in establishing a reliable and effective method for evaluating cleaning processes based on risk. Click here to view a PDF of this article.
Latest:
Proposing a New Method of Detecting Pinholes in Single-UseThe increased use of single-use bags in biologic manufacturing poses the risk of pinholes and other defects that cannot currently be tested for.
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USP Proposes a New Chapter for Rapid Sterility TestingThe US Pharmacopeial Convention (USP) is developing a new chapter for rapid sterility testing of short-life products based on the recommendations of a panel of experts and stakeholders.
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High-Throughput Multi-Product Liquid Chromatography for Characterization of Monoclonal AntibodiesThese new analytical methods can reduce analysis and product development time.
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Innovations in Automation—High-Throughput Dynamic Light Scattering for Screening Biotherapeutic FormulationsThis article introduces the technology that powers automated HT–DLS and explores its practical applications in enhancing formulation stability investigations.
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Evolution of the Monoclonal Antibody Purification PlatformThe authors discuss the evolution of the purification platform for manufacturing of mAb therapeutics.
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Improving Aggregate Removal to Enhance Clinical Manufacturing of MAbsHydrophobic interaction chromatography (HIC) in flow-through mode offers a more efficient and cost-effective polishing/purification process to remove monoclonal antibody aggregates while maintaining purity at ≥99% than a mixed-mode bind/elute procedure.
Latest:
Improving Aggregate Removal to Enhance Clinical Manufacturing of MAbsHydrophobic interaction chromatography (HIC) in flow-through mode offers a more efficient and cost-effective polishing/purification process to remove monoclonal antibody aggregates while maintaining purity at ≥99% than a mixed-mode bind/elute procedure.
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Assessing Viral Inactivation for Continuous ProcessingTesting demonstrates an automated semi-continuous process strategy for viral inactivation with steps that mimic batch processing.
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AAPS Traces the Path to ICH M10Efforts strive to harmonize bioanalytical method validation for non-clinical and clinical studies.
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Supplier-Change Management for Drug-Product ManufacturersAn effective supplier-initiated change management process is discussed.
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Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic DrugsAnalytical exoglycosidases are transitioning from being largely academic tools to being suitable for glycan analytics in biopharmaceutical manufacturing.
Latest:
Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic DrugsAnalytical exoglycosidases are transitioning from being largely academic tools to being suitable for glycan analytics in biopharmaceutical manufacturing.
Latest:
Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic DrugsAnalytical exoglycosidases are transitioning from being largely academic tools to being suitable for glycan analytics in biopharmaceutical manufacturing.
Latest:
Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic DrugsAnalytical exoglycosidases are transitioning from being largely academic tools to being suitable for glycan analytics in biopharmaceutical manufacturing.
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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.
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.
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.
