Newsletter | July 16, 2026

07.16.26 -- Is Your AI Model Trustworthy & Credible In GMP Processes

INDUSTRY INSIGHTS

The Patent Cliff Looms – Design Your Biosimilar Approach Accordingly

In your pursuit of developing a high-quality biosimilar, think strategically. Consider what type of biologic your team’s expertise can support and which is needed most in your target market.

FEATURED EDITORIAL

A Comparison Of 6 Analytical Validation Guidelines Using Data Envelopment Analysis

This is the first published application of data envelopment analysis to six major pharmaceutical analytical validation guidelines, including ICH Q2(R2), USP, ChP, and Brazil's ANVISA.

Use Of AI In FDA Inspection Activities: Strategies For Effective Preparation

Are you ready? FDA has begun to implement the use of artificial intelligence in its operations, particularly during inspection activities.

Where Does 3D-Printed Single-Use Tech Fit In The Development Pipeline?

Additive manufacturing in early-phase process development is growing more common, but the practice comes with important considerations.

Is Your AI Model Trustworthy And Credible In GMP Processes?

Credibility and trustworthiness in AI models are related but distinct attributes. If you're using them in GMP manufacturing, you should understand the difference.

SOLUTIONS

Real-Time Monitoring And Automated Sampling For Enhanced Efficiency