Authors
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Labs on the Frontlines: Balancing Re-Entry and the Race to a COVID-19 CureHow real estate can accelerate productivity as life sciences companies prioritize COVID-19 therapeutics, vaccines, and new diagnostics R&D amidst new guidelines.
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Protecting Intellectual Property in Engagements with CMOsImportant IP contractual provisions should be included when working with CMOs.
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Mastering Cell Bank ProductionA thorough cell-bank testing plan is necessary to certify the safety and purity of a resulting biopharmaceutical product.
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Mastering Cell Bank ProductionA thorough cell-bank testing plan is necessary to certify the safety and purity of a resulting biopharmaceutical product.
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Mastering Cell Bank ProductionA thorough cell-bank testing plan is necessary to certify the safety and purity of a resulting biopharmaceutical product.
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Establishing Process Design Space for a Chromatography Purification Step: Application of Quality-by-Design PrinciplesThis case study reviews how quality-by-design principles can be implemented in an intermediate chromatography purification step that uses cation-exchange chromatography.Abstract
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Minimization of Freeze/Thaw-Induced Protein Aggregation and Optimization of a Drug Substance Formulation MatrixThe authors explore the use of statistical experimental design and multivariate analysis to develop a drug substance formulation matrix.
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Optimizing Cation-Exchange Chromatography with High-Throughput Process Development for mAb PurificationOptimization of each phase in a chromatographic cycle has a positive impact on productivity.
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Targeted Delivery of Gene and Cell TherapiesGene and cell therapies represent the next-generation treatments for a wide range of diseases, but one challenge in the development of these therapeutics is the controlled delivery to the targeted site to maximize expression or engraftment while limiting systemic exposure.
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Minimization of Freeze/Thaw-Induced Protein Aggregation and Optimization of a Drug Substance Formulation MatrixThe authors explore the use of statistical experimental design and multivariate analysis to develop a drug substance formulation matrix.
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Practical Considerations for Demonstrating Drug Substance UniformityThe authors describe considerations and best practices for meeting drug substance uniformity.
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Stability Testing in BiopharmaThree case studies illustrate some analytical methods important for stability testing.
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Changing the Culture of Cell Culture: Applying Best Practices and Authentication to Ensure Scientific ReproducibilityRafe Swan/Getty Images; Dan WardIrreproducible preclinical research is a global, expensive, and well-recognized problem that contributes to delays a
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Changing the Culture of Cell Culture: Applying Best Practices and Authentication to Ensure Scientific ReproducibilityRafe Swan/Getty Images; Dan WardIrreproducible preclinical research is a global, expensive, and well-recognized problem that contributes to delays a
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Changing the Culture of Cell Culture: Applying Best Practices and Authentication to Ensure Scientific ReproducibilityRafe Swan/Getty Images; Dan WardIrreproducible preclinical research is a global, expensive, and well-recognized problem that contributes to delays a
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Temperature and Relative Humidity Control to Reduce Bioburden in a Closed Cell Processing and Production System without DisinfectantsControlling certain atmospheric conditions in a closed NGI processing chamber can reduce bioburden without disinfectants.
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Best Practices in Qualification of Single-Use SystemsThe author discusses the current best practices in technical qualification of single-use systems.
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Feasibility of a Rapid Microbiological Method for Filterable Raw MaterialsThe rapid microbiological growth-based method represents an alternative for the quantification of contaminants in filterable products.
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Feasibility of a Rapid Microbiological Method for Filterable Raw MaterialsThe rapid microbiological growth-based method represents an alternative for the quantification of contaminants in filterable products.
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Connecting People, Science, and RegulationPDA/FDA regulatory conference promotes a commitment to quality.
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Data Integrity: Getting Back to BasicsEnsuring data integrity involves effort on an individual and global basis.
