Sterile formulation strategies to shorten timelines for first-in-human studies


Lengthy early development timelines are common across new & emerging biotech companies for a multitude of reasons. Striking the right balance of speed, quality, risk, and investment allows you to shorten timelines and work with efficiency. Strategies adopted for a rapid development of a simple yet flexible format proves beneficial.

In recent years, with more clinical candidates being explored for niche indications, orphan drugs, and for indications with a rapid clinical end point, the pathway to the later clinical phase is short and there is not enough time to perform bridging studies. Hence a more scalable dosage form may need to be developed.

Download this whitepaper to learn how to adopt strategies that:

  • Ensure consistency across your large molecule
  • Lay the foundation for commercial success