Insights On Quality Assurance

  1. Cambrex Scientist Spotlight: Myoung Goo Kim 1/29/2025

    Myoung Goo Kim, Chemistry R&D Manager in High Point, NC, is a recognized expert in process chemistry, specializing in API manufacturing for Cambrex’s clients.

  2. Closed Sampling: Crucial For Aseptic Processing 6/26/2025

    Explore the critical role of closed sampling in bioprocessing by gaining insight into regulatory frameworks, system integrity, and aseptic practices essential to ensure compliance and product quality.

  3. Incremental Adoption Of A Modular Operations Platform 1/31/2025

    Discover the potential of a modular operations platform that scales the benefits of digitalization and aids organizations in implementing a unified data strategy to realize the full potential of smart manufacturing.

  4. Optimizing CAPA For FDA Recall Success: A Roadmap For Life Sciences Quality Professionals 12/27/2024

    Discover why an optimized CAPA process is crucial for life sciences companies to enhance quality, ensure regulatory compliance, prevent product recalls, and maintain market competitiveness.

  5. Comprehensive Peptide Mapping Of Protein Therapeutics 8/31/2023

    Explore how the peptide mapping workflows templates provided by a software designed for the characterization of biotherapeutic digests alongside data visualization and interrogation.

  6. ICH Q2 And ICH Q14 Revisions Clarify Analytical Methods For Biologics 8/30/2024

    Learn about the revisions to ICH Q2 and Q14 that provide clarification on analytical methods for biologics, aiming to ensure accuracy, reliability, and consistency in testing these products.

  7. Understanding Biosafety Levels 5/20/2024

    Compliance with biosafety levels (BSLs) is crucial in ensuring that your laboratories meet stringent standards to protect staff and prevent the escape of biological agents.

  8. Sterile Filtration And Quality Risk Management 8/31/2023

    Process control is essential for manufacturing sterile products. Explore the role of filtration for bioburden control in quality risk management and contamination control strategies.

  9. Beyond The Surface: Visible And Hidden Costs Of Quality 2/7/2025

    Hidden costs can be four times greater than visible ones. Learn how to recognize both visible and hidden quality costs to enhance management, improve customer satisfaction, and boost profitability.

  10. The Path To Digital CPV 7/9/2024

    Learn to embrace a digital CPV approach to proactively detect and address process deviations, ensuring continuous improvement and enhanced quality throughout the product lifecycle.