Authors
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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.
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Biotherapeutics Outpace Conventional TherapiesGrowth in infrastructure and process-development capabilities will be required to support the biologics market.
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Meeting Challenges for Analysis of Antibody-Drug ConjugatesThe complex structure of ADCs necessitates different analytical strategies than those for either small molecules or unconjugated monoclonal antibodies.
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Mitigating Risk for Single-Use Assemblies in Sterile FillingEvaluating the assembly design process, manufacture, and use helps mitigate risk.
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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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The Drive for Best Practice in Biopharmaceutical ManufacturingKey business considerations when developing biosimilar products virtually.
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Key Considerations in Biosimilars DevelopmentUnderstanding opportunities and challenges across all major phases of development.
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Oxidative Folding of Proteins in Escherichia ColiThe author highlights novel strains and methods that have recently been shown to express multidisulfide bonded proteins.
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Key Considerations in Biosimilars DevelopmentUnderstanding opportunities and challenges across all major phases of development.
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Correlating Product Lifecycle and Manufacturing Site Characteristics with Product DeviationsMIT survey results address product and site characteristics that statistically correlate with quality performance.
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Technology Integration: Enhancing QA and Compliance in Biopharmaceutical ManufacturingWhen developing a strategy for using technology in biopharmaceutical manufacturing, include the interaction between automation and business systems and the roles they play in enhancing quality assurance and compliance.
