White Papers

  1. 2025 State Of Validation: Key Insights 5/14/2025

    Discover what’s driving change in validation in your industry in 2025 by exploring key Insights for a first look at this year’s top trends, challenges, and opportunities in validation.

  2. 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.

  3. Handling Protocols: Key Considerations In The Highly Potent API Market 5/12/2025

    Explore the growing role of highly potent active pharmaceutical ingredients in oncology and Antibody-Drug Conjugates to highlight manufacturing challenges, safety protocols, and opportunities for CDMOs.

  4. White Paper: Characterization Of Spray Dried Biologics 5/7/2025

    Discover how spray drying can transform the formulation of complex biologics by improving stability, delivery, and functionality, with insights into the critical techniques and strategies needed for successful development.

  5. In Vivo Testing Of Nasal Dosage Forms 5/7/2025

    Innovative nasal drug delivery strategies can unlock faster, patient-friendly therapeutic solutions by combining smart formulation, advanced testing platforms, and rigorous preclinical evaluation.

  6. Compliance with Annex 1: Sterile Fill/Finish for Early Phase Clinical Supplies 5/5/2025

    Grasp the strategies for Annex 1 compliance, focusing on Contamination Control Strategy, Pre-Use Post Sterilization Integrity Testing, and critical zone controls to secure aseptic manufacturing processes.

  7. A Complete Guide To Capsule Checkweighing 5/2/2025

    Understand why accurate capsule weighing is essential for therapeutic efficacy, safety, and adherence to pharmaceutical manufacturing standards.

  8. Economic Advantage Of Robotic Gloveless Pharmaceutical Isolators 4/28/2025

    Are robotic gloveless isolators the key to smarter, safer, scalable solutions? Discover how they can revolutionize aseptic filling by reducing contamination, minimizing waste, and enhancing manufacturing flexibility.

  9. The Impact Of Annex 1 (2022) On Sterility Assurance 4/24/2025

    Airflow visualization studies, crucial for GMP compliance, validate unidirectional airflow effectiveness in contamination control. Discover their enhanced role in quality by design and revised Annex 1 guidelines.

  10. Process Analytical Technology In The ADC Bioconjugation Process 4/23/2025

    Integrating Process Analytical Technology into validated GMP processes is complex and costly, which requires thorough validation of equipment and cleaning methods. Explore more about PAT's role in ADC production.