Insights On Quality Control

  1. Comparative Study On Secondary Contamination Risk 1/31/2024

    Accurate testing results are crucial for product safety. Explore the findings of a comparative study evaluating two different platforms for the membrane filtration of microorganisms in quality control.

  2. A New Framework For Identifying Nitrosamine Risks And Derisking Products 6/18/2024

    Examine a new methodology that holds significant promise for identifying APIs at risk for NDSRI formation, enabling manufacturers to prioritize risk mitigation strategies and ensure compliance.

  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. Mitigating CMC Issues Using A Holistic Approach To Developability Assessment 3/27/2025

    Comprehensive chemistry, manufacturing, and control (CMC) developability testing is essential to mitigate the risk of costly late-stage failures and to proactively address potential challenges.

  5. A Comprehensive Solution For Critical Sample Analysis 6/19/2024

    Discover how Germfree Laboratories overcame challenges for the Royal Canadian Mounted Police by designing a mobile lab with advanced biocontainment and state-of-the-art communication systems.

  6. Next-Gen Medium And Feeds System To Improve CHO Cell Line Productivity 6/19/2024

    Choose the right CHO medium and feed system to optimize your upstream processes and secure a seamless scaling up.

  7. Monitoring Microbial Contamination Of Mammalian Cell Cultures 2/21/2025

    Mammalian cells are widely used to produce complex processed molecules. Explore a system that effectively detects microbial contamination in mammalian cell cultures and utilizes a newly formulated lysis buffer.

  8. Advancing Cell Therapy Manufacturing: Rapid Sterility Testing 5/7/2024

    The rapid sterility test kit used in the study was able to quickly detect bacteria and fungi in complex cell therapy product matrices, detecting six species listed in USP chapter <71>.

  9. Antibody-Drug Conjugates – Catalysts For Chemistry 5/16/2024

    Review the complexities of developing linkers – chemical moieties which attach a drug payload to an antibody – and considerations when identifying a CRO for ADC research and development.

  10. Pharma Custom Isolator For Sterile Lab Process 6/19/2024

    This project showcases Germfree’s capacity to provide cutting-edge, bespoke solutions in pharmaceutical manufacturing, underpinning their dedication to innovation, safety, and quality.