Insights On Regulatory Compliance

  1. Use Of Conductivity As A Tool For On-Site Residue Management 3/7/2025

    Residues from cleaning and disinfection are under increased scrutiny in cleanrooms. A new method using conductivity measurements offers a more accurate and objective way to quantify these residues.

  2. ADC Development Grows More Complex — SPR Insights Bring Clarity 4/14/2026

    Explore how real-time kinetic analysis reveals how conjugation, linker chemistry, and drug loading influence antibody–antigen interactions, while enabling sensitive detection of anti-drug antibodies.

  3. Sterile Injectables: Why Innovation Matters More Than Ever 1/15/2026

    New technologies and regulatory changes are shaping safer, more efficient filling processes. Discover why innovation is key to protecting patients and advancing therapies.

  4. Amino Acids For cGMP Biopharmaceutical Manufacturing 10/15/2026

    cGMP-grade amino acids require more than chemical specifications. Documentation, supplier controls, traceability, and intended use shape suitability for regulated processes.

  5. Leveraging 3Rs For Superior Cell Line Characterization 7/13/2026

    Explore how non-animal methods, including next generation sequencing, are advancing biologics safety testing through the 3Rs while supporting faster adventitious virus testing and more.

  6. Trend Analysis Of Particle Monitoring Data And Defining Alert And Action Limits 9/9/2026

    Routine trend analysis of total and viable particle monitoring data helps identify operational shifts early, set statistical limits, and strengthen cleanroom contamination control strategies.

  7. Get Smoother Separations, Faster: Troubleshoot Method Development 6/18/2026

    Strong chromatography requires more than separation. Fine-tuning pH, columns, and system volume prevents poor peak shape, while modeling tools streamline optimization for reproducible results.

  8. Nitrosamines - New Requirements To Evaluate Contamination Risks 12/23/2024

    Explore nitrosamine contamination, regulatory actions, and new evaluation requirements, featuring expert insights from Dr. Ulrich Reichert on prevention and risk assessment strategies.

  9. The FDA Just Flipped The Switch On Agentic AI 2/13/2026

    Agentic AI is reshaping how FDA review, surveillance, and inspection activities operate, raising the bar for expectations. Explore how these changes will redefine regulatory engagement.

  10. Moving Beyond OEE To Operational Intelligence 4/17/2026

    OEE provides a high-level view of equipment performance, but it doesn’t explain the root causes. Learn why manufacturers need deeper insight to turn utilization metrics into meaningful improvements.