INSIGHTS ON QUALITY ASSURANCE

• Sample Preparation Automation For Immunosuppressant Drug Analysis

  Discover how automated sample prep for immunosuppressant drug analysis improves accuracy, reduces contamination, and streamlines LC-MS/MS workflows.

• Stories From The Field: Supporting Critical Steps In Fill And Finish

  Explore the critical final step in drug development—formulation and filling—and discover expert strategies that can help streamline operations, reduce risk, and enhance efficiency.

• Design Testing Strategies To Develop A Drug-Device Combination Product

  Leveraging the expertise and experience of a trusted partner can reduce risk and accelerate the time to market for drug-device combination products by creating an optimal Validation Master Plan.

• Maximize Your Laboratory Efficiency

  Gain insight into how labs can boost productivity by reducing downtime, minimizing errors, and increasing walk-away time through real-time insights and analytics.

• 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.

• Automated Immunoassay For AAV Capsid Titer Measurement

  9/30/2025

  Explore how automated immunoassays outperform ELISA in AAV quantitation—offering better sensitivity, precision, and matrix interference management to help you identify the best media for high viral titers.

• Validation Of A Sterilization Process: Part 3

  9/9/2025

  Explore the full scope of sterilization activities and gain key insights into cycle development and validation using BI and BB methods to ensure product sterility and regulatory compliance.

• What Is The Biggest Problem With Inspector Training And Qualification?

  8/25/2025

  Discover how a truly blind system eliminates bias from the human inspection process, improving data accuracy and validation of automated inspection systems.

• Why And Where To Monitor In Aseptic Processing Areas

  4/24/2025

  Annex 1 mandates a risk assessment to identify optimal sample point locations. Explore factors in risk assessment, equipment selection, and system design to maximize data value.