Insights On Quality Assurance

  1. Introduction To The 3 Pillars 8/1/2023

    To optimize and standardize cell line development that benefits downstream work, organizations must focus on technology and expertise in three key areas: automation, analytics, and digitalization.

  2. Innovative Strategies For Residual DNA And Viral Titre Quantitation 5/22/2025

    Discover how digital PCR improves the accuracy of residual host cell DNA and viral titre quantification in biotherapeutic manufacturing to enhance product quality, safety, and regulatory compliance.

  3. 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.

  4. The Impact Of The FDA's New CSA Draft Guideline 2/24/2025

    Ensure product quality and patient safety by examining the FDA's draft guideline on Computer Software Assurance that emphasizes a risk-based approach to streamline software validation.

  5. This Is Your Team At Cambrex 1/29/2025

    We’re committed to helping our customers succeed and tackling challenges of any size. Meet the team of experts you’ll love collaborating with.

  6. Cambrex Scientist Spotlight: Jonas Nilsson 1/29/2025

    Jonas Nilsson, Principal Scientist based in Karlskoga, Sweden, leads a team of synthetic chemists focused on process development and optimization.

  7. Why Manual CQV Costs More Than You Think 5/6/2025

    Discover how modernizing commissioning, qualification, and validation processes in pharmaceutical and biotech manufacturing can streamline operations, reduce risks, and enhance efficiency to ensure compliance.

  8. Service Solutions Designed To Help You Gain Speed To Clinic And Market 4/28/2025

    Discover how speed, cost, and regulatory acceptance impact drug manufacturing, as well as learn about aseptic filling challenges and how innovative services can enhance your efficiency and compliance.

  9. Digital Twins And Mechanistic Models For Optimized Bioprocessing 3/24/2025

    Integrating AI and having a robust IT infrastructure is crucial for modernizing your processes. Discover how digital twins and mechanistic modeling are revolutionizing biomanufacturing, enhancing efficiency, and reducing costs.

  10. Get More Insight And Value Out Of Your Electronic Batch Record Data 2/2/2024

    Explore a cloud-based alternative to Electronic Batch Record (EBR) software that is well-suited for small to mid-sized biotech or CGT companies.