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Freeze-Thaw Performance and Robustness Assessment of Celsius FFT 6LA case study assesses freezing time and physical robustness under stress.
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The Impact of Disposables on Project Economics in a New Antibody Plant: A Case StudyA case study compares capital costs, operating expenses, and NPV for a new MAb plant.
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Faking ItDrug counterfeiting has become a major problem for the FDA today; a variety of solutions is needed.
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The Impact of Disposables on Project Economics in a New Antibody Plant: A Case StudyA case study compares capital costs, operating expenses, and NPV for a new MAb plant.
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The Impact of Disposables on Project Economics in a New Antibody Plant: A Case StudyA case study compares capital costs, operating expenses, and NPV for a new MAb plant.
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A New Paradigm in Drug DevelopmentThe changing regulatory and manufacturing environment is ushering in a new approach to drug development.
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Rapid Process Development for High Yield Plasmid DNA Fed-batch FermentationHow to reduce plasmid-mediated metabolic burden for higher yields.
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Rapid Process Development for High Yield Plasmid DNA Fed-batch FermentationHow to reduce plasmid-mediated metabolic burden for higher yields.
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Rapid Process Development for High Yield Plasmid DNA Fed-batch FermentationHow to reduce plasmid-mediated metabolic burden for higher yields.
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QbD and GMPs: How the Convergence of Science and Compliance Will Change the Way We WorkThe focus on the design space will lead to a new workspace, and will affect staff in the development, manufacturing, and quality functions.
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Finding the Balance in Managing the Quality and Efficiency of the Supply ChainAn enterprise-wide quality management initiative is required to maintain supplier quality without sacrificing bottom-line objectives.
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Apply the "Butterfly Effect" to Streamline Your Supply ChainSmall changes can have a big effect further downstream in your manufacturing processes.
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QbD and GMPs: How the Convergence of Science and Compliance Will Change the Way We WorkThe focus on the design space will lead to a new workspace, and will affect staff in the development, manufacturing, and quality functions.
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Fermentation Process Technology Transfer for Production of a Recombinant Vaccine ComponentThe authors describe challenges faced in transfer and scale-up of a fermentation process.
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Comparison of Camelid Antibody Ligand to Protein A for Monoclonal Antibody PurificationA stable alternative to Protein A chromatography.
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Strategic Outsourcing of Media Design and Cell Culture Media ManufacturingTo select the right partner for media design and optimization services, several key factors must be considered.
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Comparison of Camelid Antibody Ligand to Protein A for Monoclonal Antibody PurificationA stable alternative to Protein A chromatography.
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Strategic Outsourcing of Media Design and Cell Culture Media ManufacturingTo select the right partner for media design and optimization services, several key factors must be considered.
Latest:
Strategic Outsourcing of Media Design and Cell Culture Media ManufacturingTo select the right partner for media design and optimization services, several key factors must be considered.
Latest:
Comparison of Camelid Antibody Ligand to Protein A for Monoclonal Antibody PurificationA stable alternative to Protein A chromatography.
Latest:
Comparison of Camelid Antibody Ligand to Protein A for Monoclonal Antibody PurificationA stable alternative to Protein A chromatography.
Latest:
Strategic Outsourcing of Media Design and Cell Culture Media ManufacturingTo select the right partner for media design and optimization services, several key factors must be considered.
Latest:
Strategic Outsourcing of Media Design and Cell Culture Media ManufacturingTo select the right partner for media design and optimization services, several key factors must be considered.
Latest:
Strategic Outsourcing of Media Design and Cell Culture Media ManufacturingTo select the right partner for media design and optimization services, several key factors must be considered.
Latest:
Strategic Outsourcing of Media Design and Cell Culture Media ManufacturingTo select the right partner for media design and optimization services, several key factors must be considered.
Latest:
Strategic Outsourcing of Media Design and Cell Culture Media ManufacturingTo select the right partner for media design and optimization services, several key factors must be considered.
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Patenting Biotechnology Inventions Will Become More ChallengingRecent patent rulings raise significant patentability questions for DNA sequence inventions.
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Multi-Purpose Biopharmaceutical Manufacturing Facilities Part 1: Product Pipeline ManufacturingA multi-purpose biopharmaceutical manufacturing facility using a matrix of multi-functional cleanrooms can be adapted to efficiently meet the capacity challenges of both supplying clinical trials and launching products.
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Comparing Facility Layout Options for Managing Business and Operating RisksThe authors present a risk analysis of the impact of various business and operating risks on three facility layout strategies.
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Implications of Trace Levels of Redox-Active Metals in Drug-Product FormulationThe presence of minute amounts of chelators can help minimize the degradation of monoclonal antibodies.
