Authors
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Aggregation of Monoclonal Antibody Products: Formation and RemovalAggregate formation is influenced by multiple aspects of the bioproduction process but can be mitigated by good process design and control.
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Standards-Setting Activities on ImpuritiesUSP's focus in 2013 involves standards relating to organic impurities, measurement of residual DNA and host-cell proteins in biotechnology products, and elemental impurities.
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Standards-Setting Activities on ImpuritiesUSP's focus in 2013 involves standards relating to organic impurities, measurement of residual DNA and host-cell proteins in biotechnology products, and elemental impurities.
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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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Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and BetterTraditional project decision-making vs. a QbD approach.
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Closures for Pharmaceutical Preparations: A Review of Design and Test ConsiderationsThe author examines the use of closures for products intended for injection.
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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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Gastric-State-Controlled Bioequivalence StudiesEstablishing bioequivalence is difficult for drugs with high inter-subject variability or strong dependence on the physiological state of the gut.
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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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Optimizing Global Biopharmaceutical Operations Through Risk Mitigation and ManagementA UC Berkeley survey provides insight into biopharma's risk concerns and strategies.
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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.
