Authors
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Integrating CMC Document Preparation into the Development Process for Vaccine INDsVaccine process development is complex, and so are the documents required before clinical trials begin. Technical writers and editors can effectively coordinate the timely authoring, reviewing, and auditing of regulatory documents, minimizing filing delays.
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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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Evaluation of Dendritic Cell Products Generated for Human Therapy and Post-Treatment Immune MonitoringEmerging therapies pose challenges for standardizing QC.
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Protein Peptide Purification using the Multicolumn Countercurrent Solvent Gradient Purification (MCSGP) ProcessA new method for MAb purification.
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The Development and Application of a Monoclonal Antibody Purification PlatformA purification scheme to maximize the efficiency of the purification process and product purity while minimizing the development time for early-phase therapeutic antibodies.
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Increasing Capacity Utilization in Protein A ChromatographyA twin-column periodic countercurrent capture process that combines an efficient sequential, countercurrent loading process with a minimal twin-column hardware configuration is described.
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Increasing Efficiency in Protein and Cell Production by Combining Single-Use Bioreactor Technology and PerfusionAn off-the-shelf, single-use perfusion system.
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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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Key Considerations for Development and Production of Vaccine ProductsChallenges of vaccine development include regulatory, technical, and manufacturing hurdles in translating a vaccine candidate into a commercial product.
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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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The Therapeutic Vaccine Potential of MIS416 AdjuvantThis article discusses the potential of MIS416 adjuvant, a vaccine adjuvant and immunogen co-delivery system, to provide adequate immunostimulation to overcome host factors that may limit the success of therapeutic vaccines.
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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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Detection of Cache Valley Virus in Biologics Manufactured in CHO CellsAvoid manufacturing failures by effective viral inactivation.
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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.
