Authors
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Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and BetterTraditional project decision-making vs. a QbD approach.
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Securing and Qualifying Single-Use TechnologiesThe authors suggest techniques for mitigating risk and securing the supply chain for single-use components used in biopharmaceutical manufacturing.
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Definition of a Security Value Determined by Limulus Amebocyte Lysate Assay Targeting the Recombinant Human Epidermal Growth FactorThe correlation between limulus amebocyte lysate (LAL) assay and rabbit pyrogen test (RPT) targeting recombinant human epidermal growth factor (rhEGF) as active molecule was assessed.
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Securing and Qualifying Single-Use TechnologiesThe authors suggest techniques for mitigating risk and securing the supply chain for single-use components used in biopharmaceutical manufacturing.
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Correlating the Results from Chemistry AnalyzersRegression analysis determines the offsets between different methods and instruments that analyze cell media.
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Best Practices in Adopting Single-Use SystemsKey considerations for implementing single-use components or platforms when moving from research to process development.
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Control Strategies for Synthetic Therapeutic Peptide APIs Part II: Raw Material ConsiderationsUSP evaluates raw materials used in the chemical synthesis of peptides.
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Growth Kinetics of Human Mesenchymal Stem Cells in a 3-L Single-Use, Stirred-Tank BioreactorThe authors describe the growth characteristics of human mesenchymal stem cells cultured in a stirred-tank bioreactor.
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Bioconjugates: The Adaptable ChallengeConjugation of a biologic to a carrier molecule can solve problems in solubility and stability, but introduces its own challenges.
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Increasing Capacity Utilization in Protein A ChromatographyA twin-column periodic countercurrent capture process that combines an efficient sequential, countercurrent loading process with a minimal twin-column hardware configuration is described.
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Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic ProductsEstablishing the CQAs of a mAb product by evaluating impact and uncertainty during risk assessment.
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Downstream Purification and Formulation of Fab Antibody FragmentsAntibody fragments pose unique challenges in recovery, purification, and formulation.
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Misconceptions of Maintenance and Reliability: A Biopharmaceutical Industry Survival GuideThe authors provide common misconceptions and key concepts behind reliability engineering.
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Reliable and Objective Antibody Analysis with the New Agilent ProteoAnalyzer SystemThis technical overview compares the characterization of NISTmAb using the ProteoAnalyzer with published NIST data obtained via traditional single capillary CE-SDS technology. The results show strong correlation with the reference data, confirming that the ProteoAnalyzer is a reliable tool for analytical workflows.
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A Generic Growth Test Method for Improving Quality Control of Disposables in Industrial Cell CultureQuality control for disposable-bags
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Growth Kinetics of Human Mesenchymal Stem Cells in a 3-L Single-Use, Stirred-Tank BioreactorThe authors describe the growth characteristics of human mesenchymal stem cells cultured in a stirred-tank bioreactor.
Latest:
Growth Kinetics of Human Mesenchymal Stem Cells in a 3-L Single-Use, Stirred-Tank BioreactorThe authors describe the growth characteristics of human mesenchymal stem cells cultured in a stirred-tank bioreactor.
Latest:
Growth Kinetics of Human Mesenchymal Stem Cells in a 3-L Single-Use, Stirred-Tank BioreactorThe authors describe the growth characteristics of human mesenchymal stem cells cultured in a stirred-tank bioreactor.
Latest:
Definition of a Security Value Determined by Limulus Amebocyte Lysate Assay Targeting the Recombinant Human Epidermal Growth FactorThe correlation between limulus amebocyte lysate (LAL) assay and rabbit pyrogen test (RPT) targeting recombinant human epidermal growth factor (rhEGF) as active molecule was assessed.
Latest:
Downstream Purification and Formulation of Fab Antibody FragmentsAntibody fragments pose unique challenges in recovery, purification, and formulation.
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Optimizing microfluidic LNP formulations with in-line particle size and concentration measurementsThursday, November 17, 2022 Session 1: 8 am PST | 11 am EST | 5 pm CET Session 2: 10 am CET | 9 am GMT | 6 pm JST Session 3: 10am JST | 5 pm PST Learn how to automate LNP production with in-line particle size and concentration measurements using multi-angle light scattering (MALS) and dynamic light scattering (DLS).
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An Integrated Prefilled Syringe Platform Approach for Vaccine DevelopmentAn integrated focus on product design, development, operation, and control.
Latest:
Definition of a Security Value Determined by Limulus Amebocyte Lysate Assay Targeting the Recombinant Human Epidermal Growth FactorThe correlation between limulus amebocyte lysate (LAL) assay and rabbit pyrogen test (RPT) targeting recombinant human epidermal growth factor (rhEGF) as active molecule was assessed.
