DNA To IND In 13 Months: A CMC Strategy For Bispecifics

By Andrew Brown, Support Manager, Global Process Development

The success of multi-chain protein biotherapeutics, such as bispecific molecules used for the treatment of cancer, neurological and ophthalmic disorders, and autoimmune and inflammatory diseases, is driving an increase in the number of these molecules within clinical trials and receiving commercial approval. However, the complexity of their development and manufacture calls on innovative tools and technologies to facilitate their clinical journey while avoiding costly setbacks. In its commitment to innovation and the delivery of novel molecular formats, Lonza has designed a CMC strategy for bispecific molecules that enables delivery of a data package for IND submission within 13 months*. This strategy offers customers an end-to-end comprehensive DNA-to-IND offering with reliable timelines backed by Lonza’s decades of experience in biologics and investment in cutting-edge technology, which reduces risk and increases speed to clinic.

Download the full article to learn more about this strategy as well as case studies of its application in vector, process, analytic, and formulation development of bispecific molecules during pre-clinical development.