Insights On Regulatory Compliance

  1. Analytical Strategies For Impurity Control In Antibody-Drug Conjugates 7/16/2025

    Antibody-drug conjugates (ADCs) combine antibody targeting with potent cytotoxic payloads to treat resistant cancers, but their complexity requires phase-appropriate analytical strategies.

  2. Viral Disinfectant Efficacy Studies: Key Guiding Factors And Design Elements 4/8/2025

    Achieving compliance and safety through Disinfectant Efficacy Studies (DES) is about adhering to regulations and committing to high standards of safety and quality of manufacturing operations.

  3. Tackling Residual DNA Testing In Biotherapy Manufacturing 7/16/2025

    Controlling residual host cell DNA is critical for the safety and efficacy of biotherapeutics. Learn about robust, highly sensitive analytical methods for effective DNA clearance and process control.

  4. A Shift Towards Biofluorescent Particle Counters In Manufacturing 5/12/2025

    Sterility in injectable drug manufacturing is vital for patient safety and efficiency. Discover how biofluorescent particle counters revolutionize contamination control, regulatory compliance, and operational excellence in modern pharma.

  5. Successful Microbial Testing And Identification 5/27/2025

    In this presentation, one of our industry-leading customers discusses how they've successfully implemented the Applied Biosystems MicroSEQ Microbial Identification System in their laboratory testing.

  6. The Unintended Consequences Of The Inflation Reduction Act (IRA) 10/21/2024

    Cencora PayerPulse provides insights into market access trends and the Inflation Reduction Act's impact on Medicare Part D, based on research from 41 advisors.

  7. What Is The Position Of Regulatory Authorities On PUPSIT? 5/2/2025

    PUPSIT and other integrity testing methods are crucial for manufacturers to reduce contamination risks and ensure drug product safety. Learn how your company can adhere to updated regulatory guidelines.

  8. The Benefits Of Automating Your Requirements Traceability Matrix 7/23/2025

    The Requirements Traceability Matrix ensures every system requirement is verified through testing, supporting compliance, reducing risk, and strengthening validation efforts across development.

  9. How To Solve Complex Pediatric Dosing Challenges Using Tailored Solutions 8/11/2025

    With a partner who understands the science, the regulations, and the real-world demands of dosing children, development can move faster, smarter, and with greater confidence

  10. The Patent Cliff Looms – Design Your Biosimilar Approach Accordingly 3/3/2025

    In your pursuit of developing a high-quality biosimilar, think strategically. Consider what type of biologic your team’s expertise can support and which is needed most in your target market.