Downloads

1. Use Of AI In FDA Inspection Activities: Strategies For Effective Preparation 6/8/2026

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

2. A Comparison Of 6 Analytical Validation Guidelines Using Data Envelopment Analysis 6/5/2026

   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.

3. 20% Ethanol With WFI In Single Use Bags 6/4/2026

   Formulated to 19.0%–21.0% v/v from USP-grade components, this ready-to-use ethanol solution ships in IPEC/ISO 9001-compliant single-use bags with aseptic dispensing and direct sampling connections built in.

4. The Essential Ingredient For GxP Training Innovation 6/4/2026

   Advanced learning tools depend entirely on the health of the underlying training matrix. Establish a clean, data-driven framework to reduce compliance risks and recover lost operational hours.

5. Efficient mAb Development With A Flexible Purification Toolkit 6/4/2026

   Increasing mAb complexity is pushing purification beyond traditional platforms. See how flexible chromatography, optimized buffers, and adaptable workflows are becoming essential to achieve target purity.

6. Performance Starts With Better Delivery 6/4/2026

   Drug delivery strategy drives effectiveness and outcomes. Advances in formulation and dosing enable precise, scalable solutions to overcome development challenges and boost performance.

7. Managing Organic Impurities And Nitrosamines In APIs 6/4/2026

   How API manufacturers can assess and mitigate organic impurities and nitrosamines using risk-based strategies aligned with global regulatory expectations.

8. Faster Clones, Simpler Process: What's Changing In CHO Expression? 6/3/2026

   This presentation examines how enhanced glutamine synthetase selection stringency, combined with a high-strength gene promoter, provides greater control over gene expression and supports CHO cell line development.

9. How Solid-State Science Solves Your Toughest API Challenges 6/3/2026

   Difficult small molecules demand more than standard purification strategies. See how combining solid-state expertise with advanced chromatographic modeling improves filtration, purity, and scalability.

10. 2026 Critical Manufacturing Trends Reshaping Pharma & Medical Device 6/3/2026

    Discover how modern life sciences manufacturers integrate digital threads and validated AI frameworks to eliminate operational silos, build supply chain resilience, and upskill the modern workforce.