Authors
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Comparing Protein A Resins for Monoclonal Antibody PurificationA prototype Protein A resin is evaluated for purification performance, reusability, and cost performance.
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In-Depth Validation of Closed-Vial TechnologyThe authors describe a validation master plan for closed-vial filling technology.
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Process Development and Spiking Studies for Virus Filtration of r-hFSHThis study on a recombinant human follicle stimulating hormone demonstrates the use of virus filters to reduce the risk of contamination.
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Concentrating Feed—an Applicable Approach to Improve Antibody ProductionDifferent approaches to prepare highly concentrated feed media for fed-batch Chinese hamster ovary cell culture are evaluated.
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In-Depth Validation of Closed-Vial TechnologyThe authors describe a validation master plan for closed-vial filling technology.
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Process Development and Spiking Studies for Virus Filtration of r-hFSHThis study on a recombinant human follicle stimulating hormone demonstrates the use of virus filters to reduce the risk of contamination.
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Efficient Prion Removal from Gonadotropin Solutions by Nanofiltration MembranesCan a nanofiltration process be leveraged for removal of prions?
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The Affordable Care Act's Impact on Innovation in BiopharmaThe biopharmaceutical industry contemplates product innovation within the changing landscape of healthcare.
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The Conception and Production of Conjugate Vaccines Using Recombinant DNA TechnologyRecombinant technology can be used to produce conjugate vaccines.
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Comparing Protein A Resins for Monoclonal Antibody PurificationA prototype Protein A resin is evaluated for purification performance, reusability, and cost performance.
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Protein EngineeringIndustrializing design, development, and manufacturing of therapeutic proteins.
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INTERPHEX 2014: New Partners, New ProgramsConference programming from PDA and BioPharm International expand educational opportunities at Interphex 2014.
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Protein EngineeringIndustrializing design, development, and manufacturing of therapeutic proteins.
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The Evolution from Fixed to Single-Use SystemsAn overview of applications for disposable components and important property considerations.
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Process Development and Spiking Studies for Virus Filtration of r-hFSHThis study on a recombinant human follicle stimulating hormone demonstrates the use of virus filters to reduce the risk of contamination.
Latest:
Concentrating Feed—an Applicable Approach to Improve Antibody ProductionDifferent approaches to prepare highly concentrated feed media for fed-batch Chinese hamster ovary cell culture are evaluated.
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Biotech World: Canada's Supreme Court says "No" to Harvard Mouseby Denise Wendt The Court's decision not to allow the patenting of higher life forms puts it at odds with Japan, europe, and the United States.
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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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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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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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The Evolution from Fixed to Single-Use SystemsAn overview of applications for disposable components and important property considerations.
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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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The Evolution from Fixed to Single-Use SystemsAn overview of applications for disposable components and important property considerations.
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AbbVie's Acquisition of Shire Could Save $8 Billion in TaxesAbbVie's relocation to Ireland following Shire's acquisition could lower its annual tax expense by as much as 7% over the next 15 years.
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Control Strategies for Synthetic Therapeutic Peptide APIs Part II: Raw Material ConsiderationsUSP evaluates raw materials used in the chemical synthesis of peptides.
