When not addressed early, solubility, stability, and scalability (3S) challenges can delay program timelines, increase costs, and introduce CMC regulatory risks.
Solubility, Stability, and Scalability (3S) are critical pillars of successful drug product CMC and commercial launch—yet shortcuts in early development can be costly to address later.
Poor solubility can limit oral bioavailability and require high pill burdens; inadequate stability can compromise product performance, increase packaging costs, and shorten shelf life; and scalability challenges can lead to process validation risks, manufacturing delays, or costly redevelopment as products approach registration and launch.
In this on-demand webinar, Thermo Fisher’s experts discuss how integrating “3S” thinking into the earliest stages of drug development creates a strong foundation for clinical and commercial success. Because solubility, stability, and scalability are closely interconnected, a holistic development strategy that balances each is essential.
Real case studies from an extensive portfolio of development challenges illustrate the tangible benefits of a proactive 3S-led approach. Our experts also highlight how the depth and breadth of an innovative CDMO partner can help integrate technical solutions to anticipate risk, streamline scale-up, and accelerate development.