Case Study

A Case Study In Real-Time Release Testing

Source: Parenteral Drug Association (PDA)

By Juan L. Torres, PhD, Biogen

Now is the time to revolutionize how both manufacturers and regulators think about biotech manufacturing in order to proactively respond to the anticipated need for vastly increased productivity and efficiency. In order to continuously improve, manufacturers must work together as an industry and in collaboration with regulators to realize the intent of Quality by Design (QbD) and ICH quality guidelines.

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Parenteral Drug Association (PDA)