chapter  5
22 Pages

Use of Experimental Design Techniques in the Qualification and Validation of Plasma Protein Manufacturing Processes

BySourav Kundu

When developing a purification process for a new plasma protein drug substance, designed experiments can be highly useful in process-parameter screening, optimization and demonstration of process robustness, similar to its use in the mainstream pharmaceutical industry described in this book by other contributors. Generally, biological products are complex mixtures with high levels of hetero geneity. Well-thought out designed experiments are the only reasonable means to resolve such complex relationships and obtain useful data.