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How to Manage Effective Leadership when Change is the Only ConstantA disciplined approach to changing behavior can achieve change agility.
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Accelerated Delivery to a Development Candidate Enabled by RapidFire_MSWebinar Date/Time: Monday, March 27th at 11am EDT|8am PDT|4pm BST|5pm CEST
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Development of an Alternative Monoclonal Antibody Polishing StepMAb polishing using salt tolerant interaction membrane chromatography.
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Scale-up of Human Mesenchymal Stem Cells on Microcarriers in Suspension in a Single-use BioreactorDemonstration of large-scale stem-cell scale-up.
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Integration of a Single-Use Platform Process within an Innovative Facility DesignThe combination of single-use platform technology with modular facility construction is a template for flexible manufacturing.
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Optimizing Drug Delivery for Modern BiologicsThis article discusses potential opportunities to improve the patient experience through formulation and delivery device technologies.
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Scale-up of Human Mesenchymal Stem Cells on Microcarriers in Suspension in a Single-use BioreactorDemonstration of large-scale stem-cell scale-up.
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Statistical Testing for Outliers: Calculating the Critical Point of the Extreme Studentized Deviation Using the Beta Inverse FunctionWhen analyzing data, you will sometimes find one value that is far from the others. Such a value is called an outlier. When you encounter an outlier, you may be tempted to delete it from the analysis. Assuming that the data point is not attributable to obvious experimental mistakes, do you keep it or delete it?
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Generating a Fully Processed AntibodyThe authors outline cell-line development and process scale-up for an antibody program in which the antibody requires additional processing by a site-specific enzyme for correct functionality.
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Seeking Accelerated Biosimilar CharacterizationThe authors describe the qualification of an assay with applications for investigating functional comparability of an originator and biosimilar drug.
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FDA and the Importance of ConfidentialityDo you have to worry about FDA releasing confidential data? Apparently so.
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Avoiding the Train WreckThe "due diligence framework" is an efficient process. But efficient is not the same as quick and easy. There are no shortcuts. The framework minimizes resource commitments and disruptions to ongoing programs and helps each side learn what it needs to know. In six steps, it converts the typical due diligence root canal into a painless filling.
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Scale up of Fed-Batch Culture to Produce Plasmid DNA in Escherichia coli (Peer Reviewed)The authors present scale-up from a 5-L fermentor to a 50-L pilot-scale using the criterion of constant power consumption per unit liquid volume.
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Key Considerations in Biosimilars DevelopmentUnderstanding opportunities and challenges across all major phases of development.
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Evaluation of Single-Use Fluidized Bed Centrifuge System for Mammalian Cell HarvestingThis article discusses the evaluation of a novel single-use fluidized bed centrifuge for harvesting of antibodies.
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Development of an Alternative Monoclonal Antibody Polishing StepMAb polishing using salt tolerant interaction membrane chromatography.
