Authors
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The Pulse: Global R&D Insights in BiopharmaceuticalsIlluminating industry trends, challenges and sentiments
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Technology Forum Series: Strategies to Prevent Drug Shortages and Resolve Capacity Challenges.***Session 1: Thursday, April 22, 2021, 10am EDT, Session 2: Thursday, April 22, 2021, 11am EDT, Session 3: Thursday, April 22, 2021, 1pm EDT*** A drug’s journey from development to manufacturing to patients is paved with roadblocks and potholes; many threats can derail bio/pharmaceutical processes. Potential solutions to such pitfalls have been discussed for years; however, few manufacturers have embraced technology and process advances to proactively ensure drug supply chain continuity.
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A Platform Approach for the Identity Testing of Multi-Component Cell-Culture MediaData acquired from osmolality, glucose, and folic acid tests provides useful information for the specific identification of cell-culture media.
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Education and Training in Biopharmaceutical DevelopmentIt is important for all of us to be well versed in the new sciences that impact the development of protein therapeutics.
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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.
