Quality by design in biotherapeutics purification:

understanding and addressing sources of process variability

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Quality by design in biotherapeutics purification:
understanding and addressing sources of process variability

The principles and methodologies of biopharmaceutical manufacturing are well established today. However, the increased molecular diversity brings new challenges for biomanufacturers. One of these challenges is how process developers might gain a deeper understanding for sources of variability and set mitigation strategies.

This white paper summarizes information around resin variability, serving as a reference and providing support for developing robust purification processes for biopharmaceuticals.

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