Resetting the DNA to IND Timeline: How Applying the Lessons Learned During the Pandemic Benefit Biologics CMC Development

In this informative white paper, WuXi Biologics delves into how WuXi Biologics addressed the critical need for speed in moving biologics from DNA to Investigational New Drug (IND) application submission. WuXi Biologics leveraged pandemic-era learnings, using multiple time-saving strategies in cell line development to not only accelerate the development of COVID-19 neutralizing monoclonal antibodies (mAbs) but also to redefine and reset the entire biologics development timeline. Their innovative strategies reduced the standard DNA to IND timeline from 12-15 months to an unprecedented 6 months (and less), ensuring timely availability of critical treatments without compromising product quality and safety.

In Part 1, the paper explores various acceleration strategies implemented during the pandemic, including transfection and cell line selection techniques, adjustments to the cell line stability program, utilization of stable pools throughout the entire project, and accelerated cell bank testing to expedite the DNA to IND timeline.  Part 2 of the paper extends beyond the pandemic, illustrating how the accelerated strategies developed during the crisis are applicable to non-emergency scenarios. By analyzing CMC programs conducted from 2020 to 2023, WuXi Biologics demonstrates how these strategies have already facilitated a 6-month DNA-to-IND timeline for biologics development, paving the way for a more agile and responsive approach in the industry.

By offering a detailed framework within cell line development and other areas within CMC development, along with a commitment to innovation, efficiency, and quality, WuXi Biologics helps ensure and enable continued progress in delivering innovative biologics to patients worldwide.  The accelerated DNA to IND timeline presented in this white paper, provide a mechanism for making a dramatic positive impact on the cost and time constraints associated with biologics development.