Insights On Facility Design

  1. PUPSIT Without The Pain: Practical Solutions For Implementation 5/6/2025

    Explore the critical role of pre-use post-sterilization integrity testing in quality risk management, as well as learn about integrity testing, wetting procedures, and innovative filtration systems for effective implementation.

  2. 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.

  3. How Robotic Isolator Technology Aligns To Annex 1 Principles 4/28/2025

    Robotic gloveless isolators provide exceptional automation to eliminate human intervention and reduce contamination risk. Discover how they ensure compliance with the EU Annex 1 guideline to enhance sterility, precision, and monitoring.

  4. 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.

  5. CDMO Uses Robotic Gloveless Isolator For Advanced Therapeutics 4/28/2025

    CDMOs must innovate production architectures to meet the demands of advanced therapeutics to ensure a reliable supply and compliance. Discover how these approaches advance modern medicine and improve patient outcomes.

  6. White Raven's Accelerated Path To GMP Certification 4/28/2025

    CDMO White Raven achieved GMP certification using an innovative aseptic filling solution in just 18 months. Discover how meticulous planning and collaboration set a new industry standard for efficiency.

  7. Why Internal Manufacturing Is Key To Meira GTx's Success 4/23/2025

    CEO Zandy Forbes shared Meira’s origin story and how building an in-house manufacturing facility allows the company to develop an expansive pipeline of gene therapies.

  8. Sustainable Manufacturing Through Efficient BioProduction Unit Operations 4/23/2025

    Delve into the critical environmental and economic aspects of bioprocessing. Explore the urgent need to manage the industry’s growing plastic waste issue and a three-pronged approach to address this challenge.

  9. 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.

  10. Overcoming Facility Constraints Posed By Process Intensification 4/14/2025

    Discover how your facility's layout and process flow might limit its potential and learn about media requirements in USP and DSP to optimize your scheduling and footprint for efficient media management.