Insights On Quality Control

  1. Global Regulatory Harmonization: Comparisons In Aseptic Barrier Systems 4/20/2026

    Compare global aseptic standards from the FDA, EMA, PIC/S, and WHO. Gain insights into how advanced barrier systems harmonize international requirements to ensure sterile product integrity and safety.

  2. Why US Pharma Manufacturing Delivers Strategic Value 7/28/2026

    Domestic pharmaceutical manufacturing strengthens supply chain resilience, simplifies distribution, speeds market response, and reduces risk by aligning production with key markets.

  3. Integration Of Container Closure Integrity In Contract Manufacturing 3/28/2025

    Maintaining drug product sterility and compliance demands rigorous Container Closure Integrity (CCI) within contract manufacturing. Learn how to fortify your processes.

  4. 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.

  5. Software Simplifies 21 CFR Part 11 and Annex 11 Compliance 12/9/2024

    21 CFR Part 11 and Annex 11 regulate electronic records and signatures in biomanufacturing, ensuring data integrity, security, and compliance while enabling efficient processes and regulatory alignment.

  6. Late‑Stage Progress In Excipients For Precision Nanomedicine 5/6/2026

    View late‑stage development and GMP manufacturing of novel excipients for nanomedicines, emphasizing regulatory rigor, process optimization, analytics, and scale‑up for lipid‑based delivery systems.

  7. Activate Advanced Contamination Control Technology To Safeguard Your Cell Therapy 2/6/2026

    The most common contamination risks in cell therapy manufacturing are open processes that leverage different products, inflexible instruments, labor intensive workflows, lack of in-line monitoring, and zero failure tolerance.

  8. Mechanical Engineering Design Process For Combination Products 7/17/2026

    Mechanical engineering for combination drug-delivery devices demands more than good design — it requires data-driven risk management from specs through simulation. Learn how a structured phase approach ensures global manufacturing readiness.

  9. Predicting Softgel Stability And Shelf Life Using Accelerated Modeling 7/15/2026

    Predict ibuprofen softgel shelf life in 21 days instead of years. ASAPprime modeling identified PEG-ester degradants as the limiting factor, estimating 5.5-year and 3.8-year shelf lives before long-term studies concluded.

  10. How To Double Up With A CDMO To Reduce Risk 12/12/2025

    Parallel operations with a CDMO can reduce risk and accelerate timelines by enabling simultaneous process development and manufacturing. Learn how this approach supports facility design.