01.22.26 -- Top 7 AI Lessons Learned

Accurately determining the smallest detectable defect in pharmaceutical packaging is essential for sterility. Learn how test sensitivity, positive controls, and regulatory standards shape CCI strategies.

RMAT qualification requires preliminary clinical evidence demonstrating the potential to address an unmet medical need. This designation grants benefits like intensive guidance and faster FDA review.

Discover key strategies for contamination control in cleanrooms, as well as contaminant sources, behaviors, and best practices for cleaning and removal to ensure high standards of product quality.

Explore how ISO 14644 and EU GMP Annex 1 shape cleanroom standards, with a focus on particle control, system accuracy, and the surprising impact of tubing length limitations.

Observe Dr. Sizun Jiang's transformative insights on spatial technologies, AI-driven cancer care, and data harmonization, which illuminate the future of oncology through innovation.

During early-stage development, utilize the key considerations outlined in this paper to avoid common pitfalls and expedite the transition from molecule to market.

Whether you aim to address bottlenecks or explore advanced techniques, gain a practical and forward-thinking perspective to streamline early-phase development with HTE and model-based approaches.

Aside from the level of shear or ‘gentleness,’ a number of other factors help determine which type of blender will work best in certain applications. Examine considerations for blender selections.

Advanced IV bag inspection technologies ensure patient safety and regulatory compliance. Read more about automated leak detection and quality control innovations to optimize your business.

Review contract manufacturing's evolution, driven by technological advancements and regulatory changes, and how CMOs and CDMOs are navigating opportunities and challenges.

Achieving regulatory confidence is paramount for safety and competitive advantage. Adherence to standards and robust risk mitigation are essential to avoid delays and detrimental outcomes.

Bridging the gap between startup and long-term sustainability requires a unified strategy. See how to transform early readiness metrics into a durable operating system that drives continuous improvements.

By leveraging the country's regulatory advantages and partnering with a New Zealand-based CDMO, international companies can accelerate approvals and navigate the regulatory pathway with ease.

Gain insight into how consolidating downstream operations into a single automated system can reduce footprint, cut processing time, and minimize manual errors to help teams work more efficiently.