INSIGHTS ON QUALITY ASSURANCE

• Connected. Intelligent. Compliant. The Next Leap In Pharma Manufacturing

  Explore how Industry 4.0 integration transforms pharma manufacturing through connected systems, data-driven insights, and predictive, compliant operations.

• Vertex On Building Risk Into Manufacturing Network Strategy

  Supply disruptions are becoming harder to predict. Explore practical strategies for continuity planning, supplier risk management, and network design to build lasting resilience.

• Characterizing The Effects Of Moisture On Pharmaceutical Materials

  Moisture impacts pharmaceutical ingredients’ stability and efficacy, causing phase changes and hydrate formation. Discovery SA enables humidity and temperature profiling for improved drug formulation.

• Improved Sensitivity For Trifluoroacetic Acid Gradients

  Here, the USP Tryptophan monograph is evaluated using two HPLC systems. Stability, sensitivity, and performance improvements are assessed with a diffusion-bonded mixer versus standard configurations.

• A Scalable Analytical Method For Quality-Driven AAV Characterization

  7/1/2026

  AEX-HPLC has emerged as a robust, GMP-compatible analytical method for accurately characterizing AAV capsid composition, enabling consistent assessment of empty, partial, and full capsids to support product quality, process development, and regulatory readiness.

• Delivering Critical Therapies With Speed And Safety

  6/26/2026

  Faster approvals depend on treating regulation as part of development, not the finish line. See how early quality planning and strong agency communication can move therapies toward patients sooner.

• Robust, High-Throughput Automated Solution For Water Endotoxin Testing

  4/21/2026

  High-throughput water endotoxin testing doesn’t have to sacrifice consistency. Gain insight into how an automated workflow delivers reliable results, low variability, and strong control recovery.

• EU And PIC/S Annex 1: CCS Shortfalls After 2 Years Of Implementation

  4/16/2026

  Explore how to elevate Contamination Control Strategies from static documents to inspection-ready, lifecycle tools, as well as practical approaches to Annex 1 compliance and risk-based CCS development.

• The Impact Of The FDA's New CSA Draft Guideline

  2/24/2025

  Ensure product quality and patient safety by examining the FDA's draft guideline on Computer Software Assurance that emphasizes a risk-based approach to streamline software validation.