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

Downstream Process Development of a Complicated Fusion Protein

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

Production of Therapeutic Proteins in CHO Cells

pDNA Manufacturing: An Optimized Platform Process

Accelerating Biologics Drug Development with an Expanding Analytical Toolkit

Regulatory Strategies for Gene Therapy Product Development

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

R&D Quality as the Foundation for Product Quality

Phase Appropriate GMPs – A Regulatory Roadmap