Pilot-to-Commercial Scale-Up for High Potency Products

Before dedicated investigations can be undertaken, it is critical to recognize early signals that may indicate failure during pilot-to-commercial scale-up. Symptoms can arise from production discrepancies, material inconsistencies, or unexpected…

How to Use CPV Signals After Commercial Scale-Up

During a recent scale-up process for a biopharmaceutical product, several symptoms were noted that prompted immediate investigation. Operators reported unexpected variations in critical quality attributes (CQAs) such as potency, pH…