Authors
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Quality Metrics and CMO AgreementFDA’s focus on the quality culture and its request for quality metrics may ensure a successful company-CMO relationship.
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Evaluating E&L Studies for Single-Use SystemsExtraction studies demonstrate approaches for evaluating single-use bio-pharmaceutical manufacturing materials.
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Evaluating E&L Studies for Single-Use SystemsExtraction studies demonstrate approaches for evaluating single-use bio-pharmaceutical manufacturing materials.
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Evaluating E&L Studies for Single-Use SystemsExtraction studies demonstrate approaches for evaluating single-use bio-pharmaceutical manufacturing materials.
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Evaluating E&L Studies for Single-Use SystemsExtraction studies demonstrate approaches for evaluating single-use bio-pharmaceutical manufacturing materials.
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The Powerful Lesson of the GSK–Whistleblower CaseThose at the top must walk the walk of uncompromising commitment to compliance
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Evaluation of a Single-Use Bioreactor for the Fed-Batch Production of a Monoclonal AntibodyDespite different material, agitation, and aeration, the performance of the disposable bioreactor is similar to that of stainless steel bioreactors.
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CDMOs: New Administration, New FrontierDespite some progress, the industry is still in a wait-and-see mode regarding the administration, Congress, and FDA.
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Impact of Manufacturing-Scale Freeze-Thaw Conditions on a mAb SolutionThe objective of this study was to assess the impact of manufacturing-scale, freeze-thaw conditions on aggregation and subvisible particle formation of a monoclonal antibody solution (mAb-A; IgG1) using a small-scale model.
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Stage 2 Process Validation: Regulatory Expectations and Approaches to Determine and Justify the Number of PPQ BatchesThe authors summarize the current regulatory expectations regarding the number of PPQ batches required and provide potential approaches that can be used to determine and justify the number of PPQ batches.
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Impact of Manufacturing-Scale Freeze-Thaw Conditions on a mAb SolutionThe objective of this study was to assess the impact of manufacturing-scale, freeze-thaw conditions on aggregation and subvisible particle formation of a monoclonal antibody solution (mAb-A; IgG1) using a small-scale model.
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Stage 2 Process Validation: Regulatory Expectations and Approaches to Determine and Justify the Number of PPQ BatchesThe authors summarize the current regulatory expectations regarding the number of PPQ batches required and provide potential approaches that can be used to determine and justify the number of PPQ batches.
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Small-Scale Syringe and Vial-Filling Capability for Development of Robust Filling Processes, Smooth Tech Transfers, and to Resolve Manufacturing Issues: Summary of Key LearningsUse of a small-scale filler can result in increased filling efficiency.
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Protecting Intellectual Property for COVID-19 InnovationsOpposition to IP protection for COVID-19 vaccines, therapies, tests and other technologies may only prevent eradication and treatment of the disease.
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Enabling Freeze-Thaw Stability of PBS-Based Formulations of a Monoclonal Antibody Part III: Effect of Glass Transition TemperatureAn approach to stabilize PBS-based formulations could provide a simple physiological solution for use of proteins in research, preclinical, diagnostics, and clinical studies, as well as commercial biotherapeutic products.
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Reconciling Sensor Communication GapsProcess controls get some upgrades to better reflect real-time conditions.
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Statistical Approaches for Determining Comparability of BiosimilarsCorrect organization and appropriate methods for demonstrating biosimilar comparability are important for supporting regulatory filings.
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Perspectives in MicroRNA TherapeuticsThe authors provide insight into microRNA biology, and the simplicity of anti-miR oligonucleotide drug delivery.
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Adapt Gold Standard CE-SDS Workflows to Meet New Demands in Biopharmaceutical DevelopmentWebinar Date/Time: Thu, Jul 10, 2025 11:00 AM EDT
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Meningitis Vaccine Manufacturing: Fermentation Harvest Procedures Affect PurificationCareful analysis of an unusual precipitate identifies defects.
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Staffing for China’s Rapidly Growing Biomanufacturing IndustryNew study shows China biopharma companies face staffing shortages.
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Downstream Processing for Cell-Based TherapiesFor cellular materials, new ultra scale-down devices inform large-scale downstream processing techniques.
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Downstream Processing for Cell-Based TherapiesFor cellular materials, new ultra scale-down devices inform large-scale downstream processing techniques.
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Improving Productivity to Drive Drug Discoveries to PatientsBiomedical researcher shares insights from a career dedicated to advancing therapeutic innovations for unmet medical needs.
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FTIR Spectroscopy as a Multi-Parameter Analytical ToolFTIR can successfully measure key characteristics of therapeutic proteins in a single step.
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FTIR Spectroscopy as a Multi-Parameter Analytical ToolFTIR can successfully measure key characteristics of therapeutic proteins in a single step.
