|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 this timeline, not only to get new medicines into the hands of patients more quickly, but also to reduce costs. AGC Biologics conducted an extensive value stream mapping exercise covering the various stages of process development, from initialization of a project with a DNA sequence, to a final process ready for scale-up and manufacturing.
AGC Biologics identified areas that presented opportunities for improvement and evaluated equipment and technologies with the potential to resolve these bottlenecks. Two high-throughput technologies were proven to reduce development timelines — details of which are presented in this article.
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