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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.
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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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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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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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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.
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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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Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and BetterTraditional project decision-making vs. a QbD approach.
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Points to Consider for Human Gene Therapy and Product Quality Control State Food and Drug Administration of ChinaIntroduction - Gene therapy is a medical intervention based on the modification of the genetic material of living cells. Currently, gene therapy is restricted in application to somatic cells.
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Virus Filtration Using a High-Throughput Parvovirus-Retentive MembraneTest procedures for a surface-modified polyethersulfone hollow-fiber filter.
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Identification and Quantification of Trace-Level Protein ImpuritiesA simple, sensitive, and universal platform for identification and quantification of trace-level protein impurities in biotherapeutics is described.
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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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Downstream Purification and Formulation of Fab Antibody FragmentsAntibody fragments pose unique challenges in recovery, purification, and formulation.
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Purification of Antibodies Using Novel Convecdiff Membranes Part 2: Robust Performance at Comparable Product QualityIn part 2 of this article, results from the testing of a next generation convecdiff membrane are discussed.
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Process Lifecycle Validation: Applying Risk ManagementThe authors discuss the application of risk management in process lifecycle validation, manufacturing, and change control.
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Applying Continuous-Flow Pasteurization and Sterilization ProcessesThe author discusses HTST pasteurization and UHT sterilization.
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Ensuring a Robust Raw-Materials Supply ChainWith globalization, biopharmaceutical companies must establish strategies to minimize vulnerabilities in the raw-materials supply chain.
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RFID in the BioPharmaceutical Supply ChainMass serialization, or the ability to store a unique serial number for each item, is the most useful feature of RFID tags.
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Kinetic Analysis of Antibodies from Different Cultured MediaAn analytical method assesses the effects of media condition on cultured antibodies.
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Scalability of the Mobius CellReady Single-use Bioreactor SystemsReview the process-design space and scalability of a single-use, stirred-tank bioreactor.
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Changing the Dynamic of CROsThrough its educational and networking opportunities, the American Association of Pharmaceutical Scientists plays an important role in partnering throughout the drug- development and commercialization process.
