Authors
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New Gene Patent RulesThe US Supreme Court's Myriad decision satisfied both patient groups and patent holders
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Optimizing Global Biopharmaceutical Operations Through Risk Mitigation and ManagementA UC Berkeley survey provides insight into biopharma's risk concerns and strategies.
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An Integrated Prefilled Syringe Platform Approach for Vaccine DevelopmentAn integrated focus on product design, development, operation, and control.
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Complementary Techniques for the Detection and Elucidation of Protein AggregationIn this article, the author reviews some of the techniques that can yield valuable information on protein stability, focusing specifically on protein aggregation. Emphasis is placed on the enhanced information made available when technologies are used orthogonally, and the alignment of different approaches with specific stages of the biopharmaceutical development workflow.
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Clearing Viral Concerns in Animal-Derived BiomaterialsViruses in animal-derived starting materials could contaminate biopharmaceutical final product. A rigorous testing strategy and removal methods are reviewed.
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Misconceptions of Maintenance and Reliability: A Biopharmaceutical Industry Survival GuideThe authors provide common misconceptions and key concepts behind reliability engineering.
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Growth Kinetics of Human Mesenchymal Stem Cells in a 3-L Single-Use, Stirred-Tank BioreactorThe authors describe the growth characteristics of human mesenchymal stem cells cultured in a stirred-tank bioreactor.
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Identification and Quantification of Trace-Level Protein ImpuritiesA simple, sensitive, and universal platform for identification and quantification of trace-level protein impurities in biotherapeutics is described.
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Optimizing Human Performance: A Road Worth Traveling, Part 3This article is the third and final in a series designed to offer leaders and managers at all levels in the industry a road map to excellence in human performance and human error prevention.
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Patents and Postapproval Batch TestingCan postapproval FDA filings immunize pharma companies from patent lawsuits?
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Managing Contract Manufacturing Organization RelationshipsSuccessful management of the CMO/client relationship should include open communication and trust.
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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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When the Process Becomes the Product: Single-Use Technology and the Next Biomanufacturing ParadigmThe move to single-use manufacturing has prompted a paradigm shift in facility design.
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Identification and Quantification of Trace-Level Protein ImpuritiesA simple, sensitive, and universal platform for identification and quantification of trace-level protein impurities in biotherapeutics is described.
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Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and BetterTraditional project decision-making vs. a QbD approach.
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Polishing Complex Therapeutic ProteinsA new downstream purification platform using a salt-tolerant membrane adsorber.
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Safety Drives Innovation in Animal-Component-Free Cell-Culture Media TechnologyAdvances in cell culture media technology have helped achieve safer biologics.
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Cellular and Gene Therapies Face a Manufacturing Capacity CrunchCellular and gene therapy fields are currently on track for, if not already experiencing, a serious capacity crunch.
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Single-Use Redundant FiltrationThe authors describe a new assembly for bulk and final drug product filling operations.
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Costing Issues in the Production of BiopharmaceuticalsOperational planning and early cost analyses are key to generating optimal, robust, and economical commercial processes.
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Ice Fog as a Means to Induce Uniform Ice Nucleation During Lyophilization (Peer Reviewed)The authors describe a novel means to control ice nucleation using a sterile cryogenic ice fog.
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A Method for Removal of Endotoxin from Pharmaceutical FormulationThe authors describe a simple method to remove endotoxins from highly viscous formulations.
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Single-Use Technology for Syringe FillingA novel approach to sterile drug product manufacturing uses a single-use assembly in a multi-product final filling suite with isolator technology.
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Unveiling CQA Insights for mRNA, LNPs, and Viral Vectors by SEC and MALS With Novel 1000 Å Ultrawide Pore Particle ColumnsWebinar Date/Time: Thu, Sep 5, 2024 11:00 AM EDT
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The Case for Pediatric ExclusivityReauthorization of pediatric exclusivity provisions looms in 2012 and debates begin anew.
