Biosimilar Manufacturing solution center

  1. Facility Considerations When Retrofitting Legacy Sites For ADCs 1/26/2026

    Antibody-drug conjugate manufacturing requires, among other things, unidirectional flow and air locks for people and materials. Facilities often lack these attributes.

  2. The 5-Layer Fix For AI Failure In Pharmaceutical Manufacturing 1/21/2026

    The promise of AI is colliding with the harsh reality of data chaos in pharma manufacturing. This article explores why most AI investments fail, and a 5-layer solution.

  3. Why Use Total Organic Carbon Analysis For Cleaning Validation? 1/21/2026

    Total organic carbon analysis is probably the most “fit for use” analytical method to validate cleaning processes, particularly within a science- and risk-based approach.

  4. Do's And Don'ts Of Material Handling When Retrofitting For ADCs 1/20/2026

    Antibody-drug conjugate manufacturing includes extremely dangerous ingredients, and most legacy facilities lack the features and flows for safe handling.

  5. Building Enterprise Resilience From QRM Signals 1/16/2026

    Turn enterprise resource management (ERM) from a checklist into a true decision system — so risk informs everyday choices before quality events become supply disruptions, delays, or regulatory exposure.

  6. Enhanced Flow Kit Performance With Leak And PUPSIT Testing 1/13/2026

    Sterile drug filtration demands rigorous integrity testing to prevent contamination. Learn how PUPSIT and in situ leak testing strengthen compliance with EU GMP Annex 1 and ensure reliable manufacturing.

  7. Automated PUPSIT For Drug Product Applications 1/13/2026

    Automated filtration systems streamline PUPSIT, leak testing, and integrity checks to ensure sterile drug product processing. Learn how these methods improve contamination control and compliance.

  8. Single-Use Standards Are Maturing, But The Process Remains King 1/13/2026

    The food industry inspired single-use in biopharma, but the regulatory landscape is far more complex. If you're worried about compliance, this discussion can help.

  9. Wetting Recommendations For Successful Filter Integrity Testing 1/12/2026

    Discover best practices for hydrophobic and hydrophilic filters, troubleshoot failures, and optimize wetting in stainless steel and single-use systems to ensure process reliability and product quality.

  10. Optimized Product Recovery Using The Drug Product Filtration System 1/12/2026

    Explore strategies to maximize drug product recovery during sterile filtration, minimize hold-up volume, and reduce dilution after PUPSIT to ensure higher yield, improved efficiency, and less waste.