By Anil Kane, Kaspar van den Dries, and Douglas Rufino
As the biopharmaceutical industry continues to evolve, the quality by design (QbD) holistic and proactive approach to drug development and manufacturing is transforming key processes. While QbD evolves from good practice to agency requirement, how can sponsors ensure that rigorous, scientific risk-based approaches are used to bring better and safer therapies to market faster?
Drug substance characterization is critical to drug product formulation, but characterization and formulation are often not integrated during drug development. This creates needless difficulties, because if drug substance (DS) chemists and drug product (DP) formulators collaborate on a formulation development strategy for early Phase I first in-human clinical studies, they can save time, money, and avoid rework.
Poorly managed postoperative pain often includes the use of opioids for pain relief and can lead to the misuse and abuse of these drugs by patients. The most effective way to stop opioid dependence is to eliminate the use of these addictive drugs after surgery altogether. This was the goal of Pacira Pharmaceuticals.
Production scale-up is rarely straightforward. Scaling up drug product manufacturing often requires time-consuming, expensive, and unexpected challenge resolution. Follow the paths of two companies as they learn how a science-led, risk-based development approach yields a more successful outcome in the long run.
Whether your company is built on a single molecule or you’re a global pharmaceutical leader, you need fast, cost-effective, and scientifically based insights during early-phase development. Leverage an innovative partner with proven expertise in early development to ensure quick problem solving, speed, and results.