Insights On Quality Control

  1. CMO Validation As A Service 8/20/2024

    Learn about the highly successful commissioning and qualification of Wheeler's Oklahoma City CDMO facility with the overarching goal of ensuring all equipment was qualified for a Phase 3 clinical production campaign.

  2. Contamination Control Of Particulate And Shuttle Blow-Fill-Seal Compliance 2/24/2026

    Does shuttle blow-fill-seal truly meet Annex 1’s stricter contamination standards? New particle burden data challenges industry assumptions and reveals what manufacturers need to know.

  3. Delving Into Gene Expression Data Analysis And Experimental Reproducibility 3/5/2026

    Scientific reproducibility is essential for credible research. Learn to navigate standardized frameworks, refine normalization techniques, and ensure your data remains transparent and verifiable.

  4. Achieving Licensing For A Healthcare Solution 6/16/2025

    Facing strict regulations and tricky powders, a healthcare client sought an advanced filling solution. Learn how an expert collaboration led to licensed product, boosting precision and productivity.

  5. Your Guide To Precise And Robust Separation Methods 11/12/2025

    Discover a detailed guide to characterizing GLP-1 receptor agonists that covers advanced LC-MS and SEC-MALS workflows for impurity profiling, stability testing, and aggregate analysis.

  6. Practical Solutions For Protein Analytics And Residual DNA Testing 11/12/2025

    Discover practical solutions for common quality control bottlenecks in biotherapy manufacturing. Learn how to improve protein analytics and DNA testing robustness and accelerate time to market.

  7. 0.45 m/s ±20% At Working Position In Closed Sterility Testing Isolators: Requirement Or Convention? 2/19/2026

    Balance compliance and efficiency in sterility testing. Explore how a risk-based approach to airflow and isolator technology aligns with Annex 1 while optimizing contamination control.

  8. Quality By Design In The Pharmaceutical Industry 12/12/2025

    Real-time release and digital quality management, powered by PAT, are driving efficiency and compliance, reshaping how manufacturers achieve speed, consistency, and competitive advantage.

  9. Accelerate Biologics Product Release With Seamless Viral Testing 6/23/2025

    Explore viral safety testing for biologics, focusing on prevention, detection, and removal strategies, updated regulatory guidance, and common challenges in unprocessed bulk testing.

  10. Ensuring Consistent Quality In Pharmaceutical Water For Injection (WFI) Systems Application Note 3/6/2026

    Maintaining high-quality water for injection is essential for pharmaceutical safety. Discover how strategic design, proactive maintenance, and risk-based monitoring ensure reliable results.