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

Multichain protein biotherapeutics such as bispecific molecules have been developed to treat cancer, neurological and ophthalmic disorders, and autoimmune and inflammatory diseases. Early successes now are driving greater numbers of such molecules toward clinical evaluation and commercial approval. However, the complexity of bispecific development and manufacture calls for innovative tools and technologies to facilitate the clinical journeys of such products and prevent costly setbacks for their sponsors.

In its commitment to fostering novel biomolecular formats, Lonza has designed a chemistry, manufacturing, and controls (CMC) strategy for bispecific molecules that can enable delivery of a data package for submission of an investigational new drug (IND) application within 13 months of DNA transfection. This strategy provides customers with a comprehensive DNA-to-IND offering with reliable timelines backed by Lonza’s decades of experience in biologics and by investment in cutting edge technology, which reduces risk and increases speed to clinic.

Get a complete insight into Lonza’a CMC Strategy For Bispecifics by accessing this report below.