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Publications Library

Your Molecule Has Met Its Match

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A Strain Development Strategy to Enhance Screening, Process Development and Scale-Up

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Downstream Process Development of a Complicated Fusion Protein

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Process Characterization & Statistical Modeling — Transforming Data into Knowledge Throughout the Product Lifecycle

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Production of Therapeutic Proteins in CHO Cells

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pDNA Manufacturing: An Optimized Platform Process

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Accelerating Biologics Drug Development with an Expanding Analytical Toolkit

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Regulatory Strategies for Gene Therapy Product Development

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Optimization of a Conventional Glycosylation Analytical Method Using Machine Learning and Experimental Design

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Conversion of a Viral Glycoprotein Titer Method from Elisa to BLI

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General Scale-up Strategies: Commonalities Between Mammalian and Microbial Processes

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R&D Quality as the Foundation for Product Quality

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Phase Appropriate GMPs – A Regulatory Roadmap

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