Insights On Facility Design

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. An Unrivaled Modular Seed Train For Process Intensification 4/14/2025

    Listen to experts as they discover a modular, perfusion-enabled seed train system and learn about the time benefits, cost benefits, and scalable process development for various production needs.

  7. Selecting A Platform Filter For High Concentration mAbs 4/9/2025

    Read more about how Fujifilm Diosynth Biotechnologies evaluated a prime filter with challenging simulant solutions and how the experimental data confirmed superior performance, which demonstrated twice the throughput.

  8. Implementation Of Multi-Column Chromatography Systems 4/4/2025

    Discover how a multi-column chromatography system enhances resin utility and enables continuous bioprocessing with minimal surge tankage for agile multi-product facilities.

  9. Meeting Demand For Enhanced Cleaning Protocols While Reducing Bioburden 3/31/2025

    Intensified cleaning protocols are vital for drug purity, yet strain conventional protein A resins. Discover how a novel resin, engineered for robust caustic resistance, ensures longevity and efficiency gains.

  10. Do Not Bear Cross Contamination In The Pharmaceutical Industry – Prevent It 3/25/2025

    Learn how thorough cleaning and process optimization in pharma manufacturing prevent cross-contamination, ensure product integrity, and enhance efficiency while also improving compliance and reducing costs.