Insights On Quality Assurance

  1. The Impact Of Annex 1 (2022) On Sterility Assurance 4/24/2025

    Airflow visualization studies, crucial for GMP compliance, validate unidirectional airflow effectiveness in contamination control. Discover their enhanced role in quality by design and revised Annex 1 guidelines.

  2. Development Of COVID-19 Vaccine Production During A Pandemic 2/20/2025

    See how seamless teamwork and automated electrophoresis systems ensured rapid, reliable COVID-19 vaccine production support and how their collaboration made a difference.

  3. A Risk-Based Approach To Validation Studies For Sterilizing-Grade Filtration And Single-Use Systems 10/3/2024

    One way to address risk related to product quality is by implementing a Question-Based Review approach. Read on to learn about this approach and its advantages.

  4. Cambrex Scientist Spotlight: Daniel Kirschner 1/29/2025

    With a Ph.D. in bioanalytical chemistry from the University of Alaska Fairbanks, Kirschner brings nearly 15 years of experience in pharmaceutical development across biotech and CDMO sectors.

  5. Digital Maturity In Life Sciences Quality And Manufacturing 6/17/2025

    Innovators in life sciences manufacturing drive life-saving breakthroughs. Amid strict regulations and complex challenges, learn how your dedication ensures quality and pushes the boundaries of what’s possible in public health.

  6. Aseptic Filling Quality Through Assurance 3/20/2026

    Meet the quality specialist who ensures every workcell is built correctly and ready for therapeutic production. His detailed final checks help confirm each system performs reliably before it leaves.

  7. Improving pKa Prediction Accuracy For PROTACs 5/28/2026

    Gain insight into how localized modeling of ionizable centers, supported by curated experimental data, delivers reliable predictions that strengthen physicochemical decision-making.

  8. How Iteration And Operational Readiness Accelerate Product-To-Patient 5/20/2026

    See how an iterative, risk‑based approach to Commissioning & Qualification shifts verification earlier, reduces late‑stage pressure, and supports smoother startups through operational readiness.

  9. Why A Dynamic, Digital Defect Library Is Now A Regulatory Expectation 9/17/2025

    Maintaining a dynamic, digital defect library is essential for modern sterile manufacturing. Learn how this approach helps ensure consistency in batch disposition and supports regulatory compliance.

  10. The Critical Role Of Product Inspection Systems In Manufacturing 4/21/2025

    Explore the vital role of product inspection systems in manufacturing as well as learn how checkweighers, metal detectors, and x-ray inspection ensure quality and safety across various industries.