INSIGHTS ON QUALITY ASSURANCE

• FDA Product Recalls: A Wake-Up Call For Life Sciences Manufacturers

  Discover why manufacturers must adopt more consumer-centric recall strategies to maintain trust and safeguard their market position.

• Scale-Up Of A Transient rAAV Production Process

  Scalable rAAV production is achievable with a transient cell line and optimized bioreactor setup, delivering high titers and reduced impurities, now validated at 200 L scale for commercial readiness.

• The Transformational Impact Of A Digital Backbone

  Relying on fragmented data becomes problematic when teams need to dissect cell line performance data and that data is not in a digital backbone.

• Navigating The Regulatory Space To Biosimilar Approval

  The biosimilar patent cliff is reshaping pharma, creating unprecedented opportunities for biotech and CDMOs. Explore expert regulatory support that can help you navigate this shift with confidence.

• Advanced Aseptic Filling Assembly Helium Integrity Testing

  10/15/2025

  Helium leak testing offers unmatched sensitivity for detecting micro-leaks in single-use fill-finish systems. Learn how tighter leak thresholds can strengthen aseptic processing and regulatory confidence.

• 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.

• Kneat Solutions Bio-Expo Live February 2025: Quality, Data, And Analytical Solutions

  3/17/2025

  Discover how top pharma companies streamline validation, reduce cycle times by 40%+, and ensure compliance with a digital validation platform that also aids in real-time reporting and compliant testing.

• Ten Ways To Solve Your Document Review Headaches In Life Sciences

  7/15/2025

  Struggling with document chaos in life sciences? Join James Wilding to uncover smart strategies and tools that streamline reviews, boost compliance, and enhance collaboration.

• Intensified Antibody Purification With Membrane Chromatography

  11/10/2025

  Learn how membrane chromatography can help overcome downstream bottlenecks in mAb purification, reduce costs, and support process intensification from development to GMP scale.