05.01.26 -- ISPE Announces 2026 FOYA Winners

Gain insight into how a systematic approach reveals impurity behavior, strengthens selectivity, and refines chromatographic conditions to build a reliable degradation method for a GLP‑1 agonist.

Regulators are increasingly favoring in vitro methods to prove bioequivalence, though differing guidelines and a new focus on matching reference product structures pose challenges.

Risk in outsourced drug development is often created, not inherent. Read how CDMO structure, continuity, and communication directly affect program risk, timelines, and outcomes.

Learn about FDA regulation 21 CFR Part 11 and the critical role it plays in ensuring pharmaceutical and medical product manufacturers properly manage and track their data.

Manufacturers face growing pressure to support personalized therapies with flexible and sustainable operations. See how success now hinges on managing context-rich data to strengthen decision-making.

Agentic AI can speed decision‑making, but only with strong governance. Find out how private deployments and governed data sources enable safe, compliant use without compromising quality.

Bowie-Dick test failures indicate serious sterilization issues. Discover the five most common causes and proven strategies to prevent downtime, compliance risks, and compromised product integrity.

Build manufacturability into your process from the start by evaluating scalability, cost, and cross-functional performance early to ensure consistent, efficient success at every stage of development.

Advance your separation and purification strategies by leveraging modern chromatography approaches that scale reliably from lab to production across small-molecule and biologics manufacturing.

Understand more about a flexible freeze container that maintains package integrity after freezing at -86 °C (-123 °F) through its durable design, minimizing product loss due to package failure.

As capacity expands and capabilities mature, CDMOs with global scale and advanced injectable expertise are becoming critical partners for bringing complex sterile drug products to market.