Insights On Quality Control

  1. Environmental Monitoring In Advanced Therapeutic Medicinal Products Facilities 3/5/2026

    Discover how to adapt your environmental monitoring framework to meet the distinct risk-management and regulatory needs of ATMP facility production.

  2. Aggregate Analysis Of Tirzepatide 12/11/2025

    A new size exclusion method effectively analyzes Tirzepatide aggregates, demonstrating robust separation and reproducibility with minimal need for organic solvents or acidic modifiers.

  3. ICH Q9 Revision 1: Enhancing Quality Risk Management 8/12/2024

    ICH Q9 Revision 1 advances the framework of Quality Risk Management (QRM) in the pharmaceutical industry, by addressing technological advancements and evolving regulatory expectations.

  4. Applying AI And Rapid Prototyping To Media And Process Development 3/26/2026

    Hear from industry experts on how teams can integrate manufacturability considerations earlier through rapid prototyping, data-driven media development, and predictive modeling.

  5. Leveraging A Modern HPLC System For Peptide Drug Substances Analysis 8/22/2024

    This study assesses a modern HPLC system within a routine QC testing environment focused on peptide-size biopharmaceuticals.

  6. How Do You Navigate GxP Compliance? 4/21/2026

    Heightened FDA scrutiny demands a shift from fragmented data to unified digital systems. Learn how to automate QA tasks, secure data integrity, and maintain a constant state of inspection readiness.

  7. Method Migration Of A Normal Phase HPLC Method For Tocopherols 9/17/2024

    The ability to migrate methods across HPLC systems is essential as systems are updated. Review a normal phase method that provides a means for quantification of tocopherols in vitamin supplements.

  8. Practical Considerations For Aseptic Gowning In Contamination Control Strategies (CCS) 2/13/2026

    Personnel remain the most significant contributor to contamination risk. Explore these practical considerations for your CCS to address complex interactions between operators and their environment

  9. Development Of Separation Methods For GLP-1 Synthetic Peptides 6/30/2025

    Explore a novel HPLC-UV/MS method for analyzing GLP-1 analogs to address critical challenges in peptide separation, impurity detection, and performance for improved reproducibility.

  10. CDMO Audit Coverage: Key Focus Areas And Compliance Objectives 12/30/2025

    CDMO audits focus on compliance, quality, performance, and relationships to reduce risk, ensure clear documentation, and align customer expectations with CDMO capabilities.