Catalent Biologics Content
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Analytical Quality By Design Using Design Of Experiments
11/21/2019
Design of Experiment (DoE) is the centerpiece of analytical Quality by Design. A DoE assay development pipeline approach delivers optimized, robust, and rugged analytical methods ready for method qualification.
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Strategies To Achieve Successful Approval & Launch
11/18/2019
Four experts share how scale-up, regulatory expectations, demand forecasting, and process validation all play a role in the success of a biologic when embarking upon the commercial manufacturing journey.
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Standardizing Process Characterization And Late Phase Development
11/18/2019
Learn an approach for process characterization to produce a monoclonal antibody, specifically at the drug substance biomanufacturing step, to improve efficiency and effectiveness.
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Characterization Of A Therapeutic mAb, Associated Antigen-Binding Fragments
10/9/2019
Determining size homogeneity of a mAb in solution is important for comparability and characterization. For this study, an IgG1 antibody was cleaved into antigen-binding fragments using pepsin and papain digestion respectively, followed by Protein A purification.
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Intensified Fed-Batch Process Using N-1 Perfusion And ambr 15
10/9/2019
Learn how to combine N-1 perfusion with the ambr®15 bioreactor system to create a powerful tool for rapid development of a highly efficient cell culture process.
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Solution To Ensure Quantity And Quality Of The Excipient Polysorbate-80 In Drug Formulations
6/10/2019
Excipients are valuable substances used to improve stability and potency, but their sourcing and stability can be a challenge. A two-method solution to evaluate one such excipient, PS-80, for quantity and quality has multiple applications for drug developers looking to utilize this in their final product.
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Comparing Batch Versus Continuous Modes
6/10/2019
This case study compares the productivity of purifications running in batch versus continuous mode. Both Protein A capture resins demonstrated increased productivity with lower buffer volume in continuous mode.
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ICP-MS Analysis Of Multiple Trace Elements In Industrial Cell Lines
6/10/2019
This poster presents an approach using trace-level multiple-element analysis through inductively coupled plasma-mass spectrometry to support upstream process development and batch quality control.
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A Novel Purification Tool's Effects On HCP Reduction, Turbidity
6/10/2019
This study involved a DoE approach to investigate effects of pH and conductivity on the turbidity, yield, and impurity clearance of the Emphaze™ AEX Hybrid Purifier and efficiency of the Protein A capture step.
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High-Throughput Formulation Dev. For High-Concentration mAbs
6/10/2019
How a high-throughput, microwell plate platform can be used to economically screen a model IgG1 mAb at 120 mg/ml in 96 formulations while minimizing protein consumed and generating large amount of data.