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The Art and Process of Successful In-LicensingUtilizing a measured approach can increase the probability for identifying search criteria that fulfill a company’s strategy.
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Applying Computational Fluid Dynamics Technology in Bioprocesses-Part 2Computational fluid dynamics can resolve performance problems.
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Freeze Bulk Bags: A Case Study in Disposables ImplementationGenentech's evaluation of single-use technologies for bulk freeze-thaw, storage, and transportation.
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Strategic Changes to a Legacy Cleaning Approach Result in a More Sustainable ProcessIn this article, the authors explored the elimination of a water rinse and blow down following the caustic wash step, examining potential safety considerations, the effect on the quality of the cleaning process, and the potential benefit of implementing this change.
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Sterilizing Filtration of Adjuvanted Vaccines: Ensuring Successful Filter QualificationFilterability and bacterial retention must be verified very early in process development to ensure successful sterilizing filtration validation.
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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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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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Quality Considerations for Peptide Manufacturing ProcessesAs a key element in the peptide production process, quality should be built into every step.
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Characterizing the Formulation Design SpaceDesign of experiments is a valuable tool for identifying aspects of a formulation that are critical to product quality.
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The Time Value of Information in Designing Downstream Purification ProcessesTo speed up the downstream process, you must get the right data, in the right amount, at the right time. Here's how.
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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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The Role of Process History in Establishing Clear Technology Transfer CriteriaSufficient process history is key to the rapid transfer of your process.
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Freeze Bulk Bags: A Case Study in Disposables ImplementationGenentech's evaluation of single-use technologies for bulk freeze-thaw, storage, and transportation.
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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.
