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Release and Stability Testing Programs for a Novel Virus-Like Particle VaccineRelease testing involves both standard potency assays and unique assays (particle size, NA activity) developed to ensure the physical, chemical, and biological stability of this type of vaccine.
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Advancing Adjuvants and Vaccine Delivery Systems for Better Vaccination StrategiesThis article presents ongoing research at VIDO-InterVac for the development of safer and more effective adjuvants. These include adjuvants that stimulate innate immunity in the body and combination adjuvants.
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Biologics: Can There Be Abbreviated Applications, Generics, or Follow-On Products?In this question-and-answer discussion of "generic" biologics, the authors contend small changes in manufacturing of biologics dramatically affect the safety and efficacy of the therapeutic molecule.
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Harvesting the Benefits of LEAN in Biopharmaceutical ManufacturingA step-by-step approach is essential for successful implementation.
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Influenza Vaccine Enhancement with Immunomodulating Peptide Thymosin Alpha 1Clinical studies have shown that treatment with thymosin alpha 1 increases response to vaccination.
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Best Practices for Microbial Fermenter Equipment CharacterizationWet testing of microbial fermenters allows for a greater understanding of the equipment's capabilities.
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Managing Cell Line Instability and Its Impact During Cell Line DevelopmentBy considering stability as part of the cell line selection and cell banking paradigm, we can ensure that instability problems are not observed during clinical or commercial manufacturing.
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Advances in Monoclonal Antibody PurificationNew technologies and adaptations of existing technologies can improve platform processes.
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A Study of Leachables for Biopharmaceutical Formulations Stored in Rubber-Stoppered Glass VialsA systematic approach facilitates formulation component selection.
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Improving Tangential Flow Filtration YieldBest methods to maximize product yield and membrane lifetime to enhance a tangential flow filtration process.
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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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Pharmaceutical Quality Success: It's All About ManagementEngaging executive leadership in the quality process is the key to compliance success.
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Chromatography Optimization StrategyRobust packing procedures can improve process performance and increase resin lifetime.
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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.
