Authors
Latest:
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.
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Virosomes: A Novel Strategy for Drug Delivery and TargetingVirosomes present novel drug-delivery vehicles with distinct advantages over liposomes.
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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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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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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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Automated Concentration and Diafiltration of Multiple siRNA SamplesProject: transfer a manual concentration/diafiltration process for siRNA production.
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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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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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Systematic Approaches to Develop Chemically Defined Cell Culture Feed MediaMaking chemically defined media work.
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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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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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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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Definition of a Security Value Determined by Limulus Amebocyte Lysate Assay Targeting the Recombinant Human Epidermal Growth FactorThe correlation between limulus amebocyte lysate (LAL) assay and rabbit pyrogen test (RPT) targeting recombinant human epidermal growth factor (rhEGF) as active molecule was assessed.
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Quantitative Post-Processing Characterization Techniques for Freeze-Dried ProductsSubjective visual evaluation of freeze-dried products can be quantified through mechanical methods of characterizing the properties these materials.
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Lyophilization: A PrimerOptimized freeze-drying cycles can offer scientific and business advantages.
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Patents and Postapproval Batch TestingCan postapproval FDA filings immunize pharma companies from patent lawsuits?
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Large-Scale Manufacturing of Plasmid DNA for Gene Therapy and DNA Vaccination -- Part 2: Toward an RNase-Free Downstream Process ? A ReviewThe medical benefits of transgenes - effective against diseases such as cancer, HIV, malaria, and tuberculosis - require either a viral or nonviral vector. Nonviral vectors have lower immunogenicity, better safety profiles, and improved stability, as well as being less expensive and easier to produce. The first article in this series reviewed techniques suitable for the purification of plasmid DNA in the absence of added RNase. This article investigates a downstream process capable of producing gram quantities of pure plasmid DNA.
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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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Aggregation of Monoclonal Antibody Products: Formation and RemovalAggregate formation is influenced by multiple aspects of the bioproduction process but can be mitigated by good process design and control.
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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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Integrating CMC Document Preparation into the Development Process for Vaccine INDsVaccine process development is complex, and so are the documents required before clinical trials begin. Technical writers and editors can effectively coordinate the timely authoring, reviewing, and auditing of regulatory documents, minimizing filing delays.
Latest:
Definition of a Security Value Determined by Limulus Amebocyte Lysate Assay Targeting the Recombinant Human Epidermal Growth FactorThe correlation between limulus amebocyte lysate (LAL) assay and rabbit pyrogen test (RPT) targeting recombinant human epidermal growth factor (rhEGF) as active molecule was assessed.
