The author describes a methodology for developing a per product qualitative and semi-qualitative business case for applying QbD to a biopharmaceutical product.
Beth H. Junker
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Beth H. Junker is the senior director of fermentation and development operations at Merck Research Laboratories
Articles by Beth H. Junker
How to optimize facility utilization and improve plant performance.
Translate the concepts in to practical applications and reduce waste.
Applying Operational Excellence Concepts to Biopharmaceutical Processing. Supplemental Tables. (PDF)
Supplemental tables for the above-mentioned article, providing additional information about the application of operational excellence methods.
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