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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.
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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.
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.
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.
