Cleanroom Whitepapers and Case Studies

  1. Improving Efficiency In Contamination Identification 7/11/2025

    Discover how rapid microbial identification using MALDI-TOF improves contamination response, shortens investigation timelines, and enhances efficiency in biopharmaceutical manufacturing.

  2. Richter BioLogics Drives Efficiency And Compliance With Unified Quality 1/21/2026

    Learn how one CDMO tripled production, improved audit readiness, and built customer trust by unifying quality systems and embracing a digital-first approach.

  3. Manufacturing Of Cytotoxic And Non-Cytotoxic Drugs In A Multiproduct Facility 10/16/2024

    The experience and expertise of the CMO is crucial to avoid the risk of cross-contamination of the drug product, as failures or weaknesses in this process can pose risk to the end-user.

  4. 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.

  5. Bio-Based Polymers Towards Net Zero In Single-Use Bioprocessing 6/13/2025

    Decarbonizing healthcare and pharmaceuticals is vital to meet climate goals and safeguard public health. Learn why these energy-intensive sectors must act swiftly to reduce emissions and navigate complex global supply chains.

  6. 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.

  7. From Open Cleanrooms To Closed Systems – What Is Driving The Change? 3/14/2025

    Aseptic processing is evolving. Regulatory changes and technological advancements are driving a shift from open cleanrooms to closed systems for sterile drug manufacturing.

  8. Advances In Regulations For Viable Environmental Monitoring 2/21/2025

    Viable air monitoring is critical for environmental monitoring programs in pharmaceutical manufacturing. Explore current regulatory standards as well as the impact of the EU GMP Annex 1 revisions.

  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. Cryogenic Storage Of IV Bags For Cell And Gene Therapies 12/18/2025

    Cryogenic storage can compromise packaging integrity for cell and gene therapies. Learn how vacuum decay technology detects micro leaks and ensures product safety under extreme conditions.