Insights On Quality Control

  1. Combat Major Cell And Gene Therapy Manufacturing Regulatory Obstacles 8/8/2023

    As cell and gene therapies grow in the pharmaceutical industry, drug sponsors must determine how to successfully navigate evolving regulations, study design considerations, and a lack of animal models.

  2. Building Control Strategies: It's Time To Go Digital 1/24/2025

    Digital control strategies in pharma enhance product quality, regulatory compliance, and efficiency by leveraging real-time monitoring, automated documentation, and Quality by Design (QbD) frameworks.

  3. The Future Of QC: Robotics And Automation 5/13/2025

    See how pharma 4.0 is revolutionizing the pharmaceutical industry with automation and digitalization to transform microbiological quality control labs into efficient, real-time-monitored environments that enhance productivity.

  4. The Right System For High-Throughput, Highly Reproducible RNA Analysis 8/14/2023

    Review the results gathered from a driver and software system when used to perform data processing on RNA samples separated by capillary electrophoresis (CE).

  5. Development To Large-Scale cGMP Production 7/25/2024

    For manufacturers working with a dry powder medium (DPM), early consultation with a supplier can increase the likelihood of success. Uncover a two-phase scale-up strategy for the production of DPM.

  6. Compressed Gas Risk Assessment: A Significant Step In Your CCS 10/10/2024

    Discover the importance of compressed gas monitoring in ensuring product quality and compliance with EU GMP standards.

  7. EMPQ And Validation Support Services 2/21/2024

    A growing pharmaceutical/biotech company hired a global consulting firm for a project that required EMPQ services for qualification activities on a newly completed aseptic processing suite.

  8. Leachables Method Development, Validation And Relevant ICH References 5/16/2025

    It is crucial to develop and validate analytical methods capable of detecting a wide range of potential organic and inorganic leachables specific to the drug and its packaging.

  9. 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>.

  10. 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.