DNA to IND In 13 Months: A CMC Strategy for Bispecifics

There is increasing demand for the development of manufacturing processes for bispecific antibodies in various molecular formats, which have more intricate product quality attributes. It’s critical the development of manufacturing processes is carried out with a design which allows resource efficiency, faster timeline to Tox/First-in-human (FIH) batch, and built-in flexibility. Lonza has applied it’s 35 years of CMC experience in Biologics to develop an end-to-end comprehensive DS/DP DNA to IND strategy in 13 months. This webinar will highlight key approaches and technologies that enable this timeline. Case study examples will be shared for application in vector, process, analytic and formulation development of bispecific molecules during pre-clinical development.