Authors
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Qualification and Validation of Single-Use Shipping SystemsThe authors provide their perspectives on shipping validation.
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Developing an Automatically Controlled Feeding Process in an E. coli Fermentation Process for Recombinant Protein ProductionAn exponential feeding strategy coupled with automation doubled protein yields while reducing fermentation time by 25%.
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The Impact of Cell Culture Medium on Cell Line and Process Development Timelines and StrategiesACF medium sped up cell-line development.
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Developing an Automatically Controlled Feeding Process in an E. coli Fermentation Process for Recombinant Protein ProductionAn exponential feeding strategy coupled with automation doubled protein yields while reducing fermentation time by 25%.
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Developing a MAb Aggregate Removal Step by High Throughput Process DevelopmentHTPD allows rapid screening of chromatographic parameters.
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Process Chromatography: Five Decades of InnovationLow-pressure process chromatography could not have developed without immense efforts to resolve scale-up issues in both column design and matrix stability.
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India's Future as a Biologics Manufacturing HubCollaborations between Western and Indian companies may provide the best path for offshoring successfully and for developing India's readiness.
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Advances in Monoclonal Antibody PurificationNew technologies and adaptations of existing technologies can improve platform processes.
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Hydrophobic Membrane Adsorbers for Large-Scale Downstream ProcessingThis alternative to column chromatography is suitable for flow-through as well as bind-and-elute purification operations.
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Release and Stability Testing Programs for a Novel Virus-Like Particle VaccineRelease testing involves both standard potency assays and unique assays (particle size, NA activity) developed to ensure the physical, chemical, and biological stability of this type of vaccine.
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Breaking the Rapid Microbiological Method Financial Barrier: A Case Study in Return on Investment and Economic JustificationA case study implementing rapid microbiological methods.
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The Impact of Cell Culture Medium on Cell Line and Process Development Timelines and StrategiesACF medium sped up cell-line development.
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Salt Tolerant Interaction Chromatography for Large-Scale Polishing with Convective MediaSTIC allows polishing to be carried out without an interstitial dilution step, which reduces process time and avoids additional buffer preparation and hold steps.
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Innovations in Intranasal Vaccine Delivery TechnologyNeedle-free vaccine delivery platforms can solve the problems of stockpiling, cold-chain management, and pandemic preparedness.
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Release and Stability Testing Programs for a Novel Virus-Like Particle VaccineRelease testing involves both standard potency assays and unique assays (particle size, NA activity) developed to ensure the physical, chemical, and biological stability of this type of vaccine.
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Advancing Adjuvants and Vaccine Delivery Systems for Better Vaccination StrategiesThis article presents ongoing research at VIDO-InterVac for the development of safer and more effective adjuvants. These include adjuvants that stimulate innate immunity in the body and combination adjuvants.
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Biologics: Can There Be Abbreviated Applications, Generics, or Follow-On Products?In this question-and-answer discussion of "generic" biologics, the authors contend small changes in manufacturing of biologics dramatically affect the safety and efficacy of the therapeutic molecule.
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Harvesting the Benefits of LEAN in Biopharmaceutical ManufacturingA step-by-step approach is essential for successful implementation.
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Influenza Vaccine Enhancement with Immunomodulating Peptide Thymosin Alpha 1Clinical studies have shown that treatment with thymosin alpha 1 increases response to vaccination.
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Best Practices for Microbial Fermenter Equipment CharacterizationWet testing of microbial fermenters allows for a greater understanding of the equipment's capabilities.
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Managing Cell Line Instability and Its Impact During Cell Line DevelopmentBy considering stability as part of the cell line selection and cell banking paradigm, we can ensure that instability problems are not observed during clinical or commercial manufacturing.
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Advances in Monoclonal Antibody PurificationNew technologies and adaptations of existing technologies can improve platform processes.
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A Study of Leachables for Biopharmaceutical Formulations Stored in Rubber-Stoppered Glass VialsA systematic approach facilitates formulation component selection.
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Improving Tangential Flow Filtration YieldBest methods to maximize product yield and membrane lifetime to enhance a tangential flow filtration process.
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Strategies for Sourcing Animal-Origin Free Cell Culture Media ComponentsHow to successfully balance patient safety with supply-chain management
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Pharmaceutical Quality Success: It's All About ManagementEngaging executive leadership in the quality process is the key to compliance success.
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Chromatography Optimization StrategyRobust packing procedures can improve process performance and increase resin lifetime.
