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Manufacturing Process Development for an Epidermal Growth Factor-Based Cancer VaccineThe Center for Molecular Immunology (Havana, Cuba) has been working on a novel cancer immunotherapy targeting the epidermal growth factor (EGF). The vaccine is composed of a chemical conjugate of EGF and a carrier protein (rP64k), designed to trigger an anti-EGF antibody response. The results of studies of molecular characterization, immunogenic activity, and clinical data are presented here.
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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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Pharmaceutical Quality Success: It's All About ManagementEngaging executive leadership in the quality process is the key to compliance success.
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Considerations When Outsourcing the Production of Clinical MaterialIt is important to understand critical aspects of the CMO's capabilities. Only by auditing certain key areas can the sponsor be assured of the quality of the materials produced.
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Considerations for Scaling-up Depth Filtration of Harvested Cell Culture FluidData on the performance and variability of different formats.
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Maximizing Yields of Plasmid DNA ProcessesRecombinant protein and plasmid DNA production using microbial expression systems is the cornerstone of many biologics manufacturing processes. HCD methods are commonly used for these processes because of the advantages they provide.
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Speed and Efficiency in Designing and Building a Monoclonal Antibodies Pilot PlantA close-up look at Pfizer's biotherapeutics plant in Shanbally, Ireland.
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Improving Protein Production in CHO CellsUsing chemically defined feeds with CHO cell lines not only eliminates the variability associated with using plant hydrolysates, but could also improve the productivity of biopharmaceutical protein manufacture and help move therapeutic proteins into clinical trials more rapidly.
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The Case for Outsourcing Biologics Process DevelopmentFour reasons why outsourcing may be the best option, and key factors to consider when selecting a provider.
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Impact of Lot-to-Lot Variability of Cation Exchange Chromatography Resin on Process PerformanceUnderstanding the impact on process performance.
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Optimizing the Primary Recovery Step in Nonaffinity Purification Schemes for HuMAbsAn alternative approach to traditional Protein A schemes is comparable in overall efficiency, product recovery, and quality.
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Plasmid DNA Recovery Using Size-Exclusion and Perfusion ChromatographyScalable method to recover plasmid-DNA.
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Speed and Efficiency in Designing and Building a Monoclonal Antibodies Pilot PlantA close-up look at Pfizer's biotherapeutics plant in Shanbally, Ireland.
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Aggregates in MAbs and Recombinant Therapeutic Proteins: A Regulatory PerspectiveFDA perspectives on specs and effective control strategies.
Latest:
Manufacturing Process Development for an Epidermal Growth Factor-Based Cancer VaccineThe Center for Molecular Immunology (Havana, Cuba) has been working on a novel cancer immunotherapy targeting the epidermal growth factor (EGF). The vaccine is composed of a chemical conjugate of EGF and a carrier protein (rP64k), designed to trigger an anti-EGF antibody response. The results of studies of molecular characterization, immunogenic activity, and clinical data are presented here.
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Best Practices for Formulation and Manufacturing of Biotech Drug ProductsHow to maintain product stability and prevent particulates.
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SEC in the Modern Downstream Purification ProcessRecent technological advances in the way biologic therapeutics are purified may bring size-exclusion chromatography back into the modern purification process.
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Impact of Lot-to-Lot Variability of Cation Exchange Chromatography Resin on Process PerformanceUnderstanding the impact on process performance.
Latest:
Improving Protein Production in CHO CellsUsing chemically defined feeds with CHO cell lines not only eliminates the variability associated with using plant hydrolysates, but could also improve the productivity of biopharmaceutical protein manufacture and help move therapeutic proteins into clinical trials more rapidly.
Latest:
Considerations for Scaling-up Depth Filtration of Harvested Cell Culture FluidData on the performance and variability of different formats.
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Advances in Single-Shot Vaccine DevelopmentThe disadvantages of the traditional vaccine regime (prime plus boost) have spurred the development of single-shot vaccines. This article describes the development and manufacture of a prototype single-shot vaccine that uses microspheres made from cross-linked modified dextran polymers for controlled release of the antigen.
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Considerations for Scaling-up Depth Filtration of Harvested Cell Culture FluidData on the performance and variability of different formats.
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Capturing Conformational Changes in Biotherapeutics by Hydrogen Deuterium Exchange and UHPLC–MSBy providing information on the relative accessibility of locations within a protein, HDX by mass spectrometry opens new windows into the higher order structure of biomolecules.
Latest:
Manufacturing Process Development for an Epidermal Growth Factor-Based Cancer VaccineThe Center for Molecular Immunology (Havana, Cuba) has been working on a novel cancer immunotherapy targeting the epidermal growth factor (EGF). The vaccine is composed of a chemical conjugate of EGF and a carrier protein (rP64k), designed to trigger an anti-EGF antibody response. The results of studies of molecular characterization, immunogenic activity, and clinical data are presented here.
Latest:
Antibody Purification Using Membrane AdsorbersA membrane adsorber in retention mode can be used efficiently in a commercial antibody manufacturing process.
