One of the key elements of any biopharmaceutical drug development project is the timeline from identification of the appropriate DNA sequence to investigational new drug (IND) application filing and the start of clinical trials. Typically, this timeline ranges from 18 to 20 months, depending on the type of molecule being developed and the extent and requirements of the chemistry, manufacturing, and controls (CMC) packages supporting the nonclinical and clinical parts of a development program. There is constant pressure to shorten…