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Developing and Manufacturing Attenuated Live Bacterial VaccinesThere are a number of specific characteristics to be considered when developing and manufacturing live bacterial vaccines.
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Validation Outsourcing: Getting the Most Out of Your Client?Contractor RelationshipSupplementing your existing staff with experienced contractors when your process is ready for validation can help you avoid common validation mishaps - if you know the ingredients of successful project management.
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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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Purification Strategies to Process 5 g/L Titers of Monoclonal AntibodiesAltering the order of operations, using new resins, and increasing dynamic binding capacity can obviate the need for major facilty changes.
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Disposable Bioreactors for Cells and MicrobesProductivities similar to those achieved with stirred tanks can be achieved with disposable bioreactors.
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Chromatography Optimization StrategyRobust packing procedures can improve process performance and increase resin lifetime.
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Leveraging Fermentation Heat Transfer Data to Better Understand Metabolic ActivityA simple method to leverage fermentation heat transfer data.
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Biobetters and the Future Biologics MarketDespite their difficult approval pathway, biobetters offer the potential for innovation and decreased healthcare costs.
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Upcoming Technologies to Facilitate More Efficient Biologics ManufacturingChoosing the right tools to enhance the process.
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Detection of Cache Valley Virus in Biologics Manufactured in CHO CellsAvoid manufacturing failures by effective viral inactivation.
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Building a Business Case for Biopharmaceutical QbD Implementation (Peer Reviewed)The author describes a methodology for developing a per product qualitative and semi-qualitative business case for applying QbD to a biopharmaceutical product.
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Advances in Non-Protein A Purification Processes for Human Monoclonal AntibodiesIn three non-affinity purification processes based on cation exchange capture with high binding capacity, applying a host cell protein exclusion strategy enabled robust scale up and better economics.
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Solutions for Purification of Fc-fusion ProteinsWhen platform processes are applied to fusion molecules, innovation and flexibility are needed.
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Economic Drivers and Trade-Offs in Antibody Purification ProcessesThe future of therapeutic MAbs lies in the development of economically feasible downstream processes.
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Handling a Risky Business: How to Ensure Successful Technology TransferEffective tech transfer can save time and effort in later manufacturing processes.
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Precipitation of Process-Derived Impurities in Non-Protein A Purification Schemes for AntibodiesPrecipitation prior to capture chromatography offers a simple, robust, and economical method to remove CHO host cell proteins and DNA.
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Costing Issues in the Production of BiopharmaceuticalsOperational planning and early cost analyses are key to generating optimal, robust, and economical commercial processes.
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Opalescence of an IgG1 Monoclonal Antibody Formulation is Mediated by Ionic Strength and ExcipientsCan increase in ionic strength result in higher viscosity?
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Leveraging Fermentation Heat Transfer Data to Better Understand Metabolic ActivityA simple method to leverage fermentation heat transfer data.
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FDA's Recommendations to Industry Regarding OutsourcingOutsourcing introduces considerable complexity into ensuring compliance with good manufacturing practices. This article offers FDA guidance for how to ensure compliance in the outsourcing environment.
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Versatility of a Single-Use Bioreactor Platform for Culture of Diverse Cell TypesAre disposable bioreactors effective for cell culture?
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Strategies for Sourcing Animal-Origin Free Cell Culture Media ComponentsHow to successfully balance patient safety with supply-chain management
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Filter Clogging Issues in Sterile FiltrationA case study investigated the root cause of failures in sterile filtration by evaluating the effects and interactions of four operating parameters.
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Developing and Manufacturing Attenuated Live Bacterial VaccinesThere are a number of specific characteristics to be considered when developing and manufacturing live bacterial vaccines.
