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Mersana Lives in a QbD World Source: Robert Essel NYC/Getty Images Share In Cambridge, MA, scientists at Mersana keep quality by design (QbD) in mind from the start when creating an antibody-drug conjugate (ADC). These combinations of an antibody and one or more drugs as many as 10 in some of Mersana’s ADCs can create complicated challenges in bioprocessing. In discussing Mersana’s multi-drug ADC platform called Dolaflexin, chief manufacturing officer Michael Kaufman, PhD, explains that the complexity requires QbD. Michael Kaufman, PhD “When you have hundreds of unit operations and thousands of parameters, you need to use a QbD approach otherwise you would spend forever trying to develop a process,” he says. “We’ve embedded QbD very early in the process development.” ....