Authors
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Securing and Qualifying Single-Use TechnologiesThe authors suggest techniques for mitigating risk and securing the supply chain for single-use components used in biopharmaceutical manufacturing.
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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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Points to Consider for Human Gene Therapy and Product Quality Control State Food and Drug Administration of ChinaIntroduction - Gene therapy is a medical intervention based on the modification of the genetic material of living cells. Currently, gene therapy is restricted in application to somatic cells.
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Virus Filtration Using a High-Throughput Parvovirus-Retentive MembraneTest procedures for a surface-modified polyethersulfone hollow-fiber filter.
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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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Misconceptions of Maintenance and Reliability: A Biopharmaceutical Industry Survival GuideThe authors provide common misconceptions and key concepts behind reliability engineering.
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Downstream Purification and Formulation of Fab Antibody FragmentsAntibody fragments pose unique challenges in recovery, purification, and formulation.
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Purification of Antibodies Using Novel Convecdiff Membranes Part 2: Robust Performance at Comparable Product QualityIn part 2 of this article, results from the testing of a next generation convecdiff membrane are discussed.
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Process Lifecycle Validation: Applying Risk ManagementThe authors discuss the application of risk management in process lifecycle validation, manufacturing, and change control.
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Applying Continuous-Flow Pasteurization and Sterilization ProcessesThe author discusses HTST pasteurization and UHT sterilization.
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Ensuring a Robust Raw-Materials Supply ChainWith globalization, biopharmaceutical companies must establish strategies to minimize vulnerabilities in the raw-materials supply chain.
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RFID in the BioPharmaceutical Supply ChainMass serialization, or the ability to store a unique serial number for each item, is the most useful feature of RFID tags.
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Kinetic Analysis of Antibodies from Different Cultured MediaAn analytical method assesses the effects of media condition on cultured antibodies.
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Scalability of the Mobius CellReady Single-use Bioreactor SystemsReview the process-design space and scalability of a single-use, stirred-tank bioreactor.
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Changing the Dynamic of CROsThrough its educational and networking opportunities, the American Association of Pharmaceutical Scientists plays an important role in partnering throughout the drug- development and commercialization process.
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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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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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Bioprocessing Technology Trends of RNA-Based Therapeutics and VaccinesThe authors present an overview of the types of RNA-based therapeutics in existence and their optimal methods of manufacture, purification, formulation, and delivery.
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Increasing Capacity Utilization in Protein A ChromatographyA twin-column periodic countercurrent capture process that combines an efficient sequential, countercurrent loading process with a minimal twin-column hardware configuration is described.
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A Generic Growth Test Method for Improving Quality Control of Disposables in Industrial Cell CultureQuality control for disposable-bags
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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.
