Authors
Latest:
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.
Latest:
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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New Strategies for a Better Glycosylation ProfileGlycan analysis provides key information on critical quality attributes that could affect stability, safety and efficacy of a protein therapeutic. Specific needs for understanding the glycosylation profiles change throughout the drug development process, but the requirement for high-resolution glycan information remains the same and is essential to help ensure product quality.
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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.
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Advancement in Single-Use Sensor Technology for Mammalian and Microbial Bioprocesses***Live: Wednesday, December 2, 2020 at 11am EST | 8am PST | 4pm GMT | 5pm CET***Learn more about the recent trends in single-use sensors to match bioprocessing needs of bioreactor, fermenters, and mixing applications. Review data from 2-year studies of sensor testing.***On demand available after final airing until Dec. 2, 2021***
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Case Study: Retrofitting Two New High Purity Water Systemsa capital investment project was required to replace the existing, obsolete high purity water (HPW) generation system and water-for-injection (WFI) generation system with new, reliable technology.
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Case Study: Retrofitting Two New High Purity Water Systemsa capital investment project was required to replace the existing, obsolete high purity water (HPW) generation system and water-for-injection (WFI) generation system with new, reliable technology.
Latest:
Case Study: Retrofitting Two New High Purity Water Systemsa capital investment project was required to replace the existing, obsolete high purity water (HPW) generation system and water-for-injection (WFI) generation system with new, reliable technology.
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Impact of PFS and Filling Process Selection on Biologic Product StabilityThe author discusses the impact of prefilled syringe product contact materials and the filling and stoppering process on protein aggregates.
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Stability Indicating Methods for Aluminum Adsorbed Vaccine ProductsThe authors provide an introduction to aluminum adsorbed vaccines, review studies of antigen stability, and propose test methods for the analysis of aluminum vaccine release and stability analysis.
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Eurofins' CMC Testing ServicesEurofins' BioPharma Product Testing offers complete CMC Testing Services for the bio/pharmaceutical industry.
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Challenging the Cleanroom Paradigm for Biopharmaceutical Manufacturing of Bulk Drug SubstancesThe authors re-examine environmental controls in the context of technical advances in manufacturing.
