Authors
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Advancing Single-Use Technology Through CollaborationBy working together to harmonize the highly variable steps within the biopharmaceutical manufacturing process, both end users and suppliers are making strides toward the efficiency and integrity of single-use technology.
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Adapting to OpportunityThe biopharmaceutical industry must continuously evolve to keep up with changing trends.
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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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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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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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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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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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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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Micro-Scale Bioreactors in Fed-batch Microbial ScreeningThe author outlines key functional attributes to assess a small-scale model.
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Lean Changeover in Biopharmaceutical Facilities: Developing A Risk-Based ApproachA streamlined approach may enhance process efficiency and product quality.
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Regulatory Reform in China: Implications for Global Biopharmaceutical CompaniesNew drug approval policies promote industry growth and injectable contract manufacturing opportunities in China.
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Generating a Fully Processed AntibodyThe authors outline cell-line development and process scale-up for an antibody program in which the antibody requires additional processing by a site-specific enzyme for correct functionality.
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Generating a Fully Processed AntibodyThe authors outline cell-line development and process scale-up for an antibody program in which the antibody requires additional processing by a site-specific enzyme for correct functionality.
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Seeking Accelerated Biosimilar CharacterizationThe authors describe the qualification of an assay with applications for investigating functional comparability of an originator and biosimilar drug.
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Quality Metrics and CMO AgreementFDA’s focus on the quality culture and its request for quality metrics may ensure a successful company-CMO relationship.
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Assessing Manufacturing Process RobustnessA structured assessment process can determine compliance to lifecycle process-validation requirements for biopharmaceuticals.
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Perfusion in the 21st CenturyQuality, flexibility, and cost savings are driving use of perfusion technology in biosimilars manufacturing.
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Perfusion in the 21st CenturyQuality, flexibility, and cost savings are driving use of perfusion technology in biosimilars manufacturing.
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Disruptive External Factors Dictate Radical Internal Changes for PharmaPharmaceutical companies need to radically change to survive and thrive amid shifting healthcare and technology changes.
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Evaluating Technology and Innovation in Biopharmaceutical ManufacturingA technology management process identifies and evaluates new technologies in biopharmaceutical manufacturing to aid business decisions.
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Evaluating Technology and Innovation in Biopharmaceutical ManufacturingA technology management process identifies and evaluates new technologies in biopharmaceutical manufacturing to aid business decisions.
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Evaluating Technology and Innovation in Biopharmaceutical ManufacturingA technology management process identifies and evaluates new technologies in biopharmaceutical manufacturing to aid business decisions.
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Evaluating Technology and Innovation in Biopharmaceutical ManufacturingA technology management process identifies and evaluates new technologies in biopharmaceutical manufacturing to aid business decisions.
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Evaluating Technology and Innovation in Biopharmaceutical ManufacturingA technology management process identifies and evaluates new technologies in biopharmaceutical manufacturing to aid business decisions.
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Enabling Freeze-Thaw Stability of PBS-Based Formulations of a Monoclonal Antibody Part III: Effect of Glass Transition TemperatureAn approach to stabilize PBS-based formulations could provide a simple physiological solution for use of proteins in research, preclinical, diagnostics, and clinical studies, as well as commercial biotherapeutic products.
Latest:
Enabling Freeze-Thaw Stability of PBS-Based Formulations of a Monoclonal Antibody Part III: Effect of Glass Transition TemperatureAn approach to stabilize PBS-based formulations could provide a simple physiological solution for use of proteins in research, preclinical, diagnostics, and clinical studies, as well as commercial biotherapeutic products.
Latest:
Enabling Freeze-Thaw Stability of PBS-Based Formulations of a Monoclonal Antibody Part III: Effect of Glass Transition TemperatureAn approach to stabilize PBS-based formulations could provide a simple physiological solution for use of proteins in research, preclinical, diagnostics, and clinical studies, as well as commercial biotherapeutic products.
