Authors
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Comparing Fed-Batch Cell Culture Performances of Stainless Steel and Disposable BioreactorsA case study to compare the performances of several types of mixing in disposable bags with stainless steel bioreactors.
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Insourcing vs Outsourcing: Choosing the Right StrategyThe article reviews strategies for firms with or without existing in-house capacities and the pros and cons for outsourcing bio/pharmaceutical development and manufacturing.
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Weighing Clinical Trial Outsourcing OptionsEvolving clinical trial research services give biopharmaceutical companies options for full and functional services.
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Increasing Efficiency in Protein and Cell Production by Combining Single-Use Bioreactor Technology and PerfusionAn off-the-shelf, single-use perfusion system.
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Practical Considerations for Demonstrating Drug Substance UniformityThe authors describe considerations and best practices for meeting drug substance uniformity.
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Comparing Fed-Batch Cell Culture Performances of Stainless Steel and Disposable BioreactorsA case study to compare the performances of several types of mixing in disposable bags with stainless steel bioreactors.
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Thermal Protection for Control-Room-Temperature ProductsThe authors discuss how to develop a cost-effective thermally protective packaging system.
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Plants As an Innovative and Accelerated Vaccine-Manufacturing SolutionA plant-based expression system could provide greater speed and capacity at a comparatively low cost.
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The Potential Application of Hollow Fiber Bioreactors to Large-Scale ProductionA hollow fiber matrix allows for efficient harvest of secreted proteins.
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Comparing Fed-Batch Cell Culture Performances of Stainless Steel and Disposable BioreactorsA case study to compare the performances of several types of mixing in disposable bags with stainless steel bioreactors.
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High-Throughput Multi-Product Liquid Chromatography for Characterization of Monoclonal AntibodiesThese new analytical methods can reduce analysis and product development time.
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Optimizing a Unique Cancer Vaccine for Intradermal DeliveryUsing a hollow microstructured transdermal system to deliver vaccine directly to the dermis.
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Sponsor-CMO Conflict Management for Clinical-Phase BiologicsThe authors present the CMO's perspective on various potential sources of sponsor-CMO conflicts.
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Evolution of the Monoclonal Antibody Purification PlatformThe authors discuss the evolution of the purification platform for manufacturing of mAb therapeutics.
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Assessing Development Needs for Biobetters and BiosimilarsDevelopment requirements and regulatory guidance for biosimilars and biobetters.
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Automated Concentration and Diafiltration of Multiple siRNA SamplesProject: transfer a manual concentration/diafiltration process for siRNA production.
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Key Considerations When Outsourcing Cell-Culture Medium DevelopmentThe authors examine several issues that will help streamline negotiations between a service provider and a cell-culture medium consumer.
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Systematic Approaches to Develop Chemically Defined Cell Culture Feed MediaMaking chemically defined media work.
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Implications of Trace Levels of Redox-Active Metals in Drug-Product FormulationThe presence of minute amounts of chelators can help minimize the degradation of monoclonal antibodies.
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Systematic Approaches to Develop Chemically Defined Cell Culture Feed MediaMaking chemically defined media work.
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Supplier-Change Management for Drug-Product ManufacturersAn effective supplier-initiated change management process is discussed.
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Managing Raw Materials in the QbD Paradigm, Part 2: Risk Assessment and CommunicationEvaluate and communicate risk to stakeholders.
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A Case Study of Developing Analytical MethodsContract manufacturers must plan for increased analytical resources in development and quality control.
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Considerations in Identification and Qualification of Spectrophotometer Equipment for Microbial FermentationsThe authors outline qualification procedures for a process-critical piece of equipment.
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Successful Technology Transfer, Process Validation, and Partnership with a CMOThe authors present lessons learned from a case study of the transfer of a cell culture biotherapeutic process to a CMO.
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Evolution of Live-Attenuated HIV VaccinesSafety concerns remain for developing replicating vectors based on the pathogen human immunodeficiency virus type 1.
