Early Decisions, Late-Stage Consequences: How The "3S's" Determine Development Success

Solubility, stability, and scalability (3S) are fundamental pillars of successful drug product CMC development and commercial launch, yet challenges in any of these areas can create significant obstacles later in development. Poor solubility may limit oral bioavailability and necessitate higher pill burdens, while inadequate stability can compromise product performance, increase packaging requirements, and reduce shelf life. Similarly, scalability issues can introduce process validation risks, manufacturing delays, and costly redevelopment efforts as products advance toward registration and commercialization.

In this on-demand webinar, Thermo Fisher experts explore how incorporating 3S principles from the earliest stages of drug development establishes a strong foundation for both clinical and commercial success. Recognizing the close interrelationship between solubility, stability, and scalability, they discuss the importance of a holistic development strategy that balances all three factors.

Through real-world examples drawn from CDMO development programs, the webinar demonstrates the practical advantages of a proactive, 3S-focused approach and highlights how the scientific depth, technical expertise, and cross-functional capabilities of an innovative CDMO partner can help anticipate risks, streamline scale-up, and accelerate development. Viewers will gain a deeper understanding of the connections between solubility, stability, and scalability, learn how integrated 3S strategies can reduce technical, regulatory, and supply chain risks, and discover how scientific expertise can support successful scale-up and commercialization.