07.24.26 -- How To Avoid The Biggest USP <665> Compliance Trap

Advance CNS-penetrant therapies by optimizing oral formulations to improve bioavailability, stabilize the API, and deliver more consistent and reliable drug exposure.

Explore how advanced synthesis platforms, integrated CMC strategies, and scalable technologies are addressing complexity, cost, and regulatory demands.

Unlock innovation in biotherapeutics with expert insights into DSC and molecular stability. Learn how biophysical techniques can optimize formulations and enhance nucleic acid stability.

Tech transfer is inherently risky due to undocumented process nuances; partnering with a single-site U.S. CDMO minimizes complexity and preserves critical knowledge through commercialization.

See how higher API activity is changing expectations around containment, scalability, and cross‑functional alignment — and why early decisions now have a greater impact on long‑term success.

Does shuttle blow-fill-seal truly meet Annex 1’s stricter contamination standards? New particle burden data challenges industry assumptions and reveals what manufacturers need to know.

Improving pediatric adherence requires age-appropriate formulations. Regulatory and technological insights help overcome barriers and support safer therapies for children across development.

Immediate, quantifiable verification replaces seven-day incubation periods. Discover how enzyme-based indicators optimize hydrogen peroxide decontamination.

This guide helps cleanroom managers evaluate sporicides by efficacy, safety, and compatibility to ensure contamination control without compromising operational integrity.

Experts discuss a solvent-free fusion process for amorphous solid dispersions, highlighting formulation flexibility, scale-up, process control, and early strategies to reduce risk and support commercialization.

Early-stage drug programs can preserve constrained API supplies by replacing large-scale manufacturing defaults with right-sized fill-finish designs that minimize avoidable process waste.

Identifying process redundancies and enhancing visual management allows manufacturers to stabilize workflows. These data-driven improvements can decrease operational variability by nearly 50%.

Find out how rethinking the synthetic strategy for Etrasimod can overcome the limitations of legacy routes, enabling more efficient control, improved scalability, and more practical API production.

Maintain pharma water quality with filtration that removes particulates, controls bacteria, and protects system components— improving reliability, reducing risk, and ensuring consistent performance.

The simultaneous spray drying of multiple ingredients is a powerful technique for making inhaled products with multiple actives. Examine how novel techniques can make these products a reality.