Accelerated formulation strategies are a useful tool to reduce development timelines and cost, but key priorities must be considered early on to ensure success.
Although in agreement that the time efficiencies are the greatest potential benefit, Jeffrey Zonderman, chief commercial officer, RedShiftBio, also specifies that faster formulation studies provide opportunities for developers to gain a more complete understanding of the drug. “With the right technology in place, formulators can screen more drug candidates, assess a wider range of excipients and buffers, and rigorously apply quality‑by‑design (QbD) principles to develop a more robust product,” he notes. “So, acceleration can lead directly to an improved drug product with better stability and a higher chance of successful commercialization. Investing in information gathering at this stage can pay dividends in terms of a lower risk of product failure and a narrower field of higher quality candidates for further development.”