Insights On Regulatory Compliance

  1. Overcoming Hurdles With A Contamination Control Strategy 7/26/2024

    Learn about the importance of a facility-specific CCS, explore common hurdles encountered in its development and get practical advice on creating a robust and compliant strategy.

  2. How Bend Bioscience Standardized Operations And Boosted Compliance 8/8/2025

    Discover how Bend Bioscience replaced its outdated CMMS with RAM to achieve rapid compliance, boost efficiency across facilities, and cut operational costs by 25%.

  3. Bioprocess Optimization: Leveraging Functional DOE With Time-Based Insights 3/5/2025

    Explore the key differences between traditional DOE and Functional DOE as Seongjin Kim demonstrates how the latter enhances bioprocess optimization through a fed-batch cell culture example.

  4. The Impact Of Instrument Characteristics On The Method Migration Of A Challenging USP Assay 9/3/2024

    To evaluate the impact of different systems on the USP monograph for azithromycin organic impurities, the organic impurities monograph was tested across multiple chromatographic systems.

  5. X-Ray Inspection For Supplement Safety 2/6/2025

    Wellington Foods ensures dietary supplement safety using METTLER TOLEDO’s X37 X-ray system, which detects contaminants, and meets regulatory standards with high-speed, precise inspection technology.

  6. Success Story: Increased Productivity With Concentrated Fed-Batch 6/30/2025

    Discover how a leading biopharma company boosted flexibility and quadrupled productivity by implementing a concentrated fed-batch process in a single-use facility.

  7. The 5 Ws Of A Human Factors Strategy 3/31/2025

    A human factors strategy ensures medical products are safe, effective, and compliant by integrating user-focused design early, reducing risks, and optimizing regulatory approval processes.

  8. Data-Driven Methods for Ensuring Container Closure Integrity 12/18/2024

    An integral component to a robust quality control program is container closure integrity testing (CCIT), which helps ensure the prevention of contamination and/or the degradation of a product.

  9. Conquering Challenges In Viral Vector Production 8/27/2025

    Scaling gene therapy demands precision and actionable data. Discover how integrated technologies like ultracentrifugation and mass spectrometry enhance AAV yield, purity, and characterization.

  10. How Particle Counting Efficiency Affects Distribution Data 6/24/2025

    Examine how counting efficiency and resolution impact data interpretation in critical environments like cleanrooms and pharmaceuticals.