Biosimilar Manufacturing solution center

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Mind The Potent Compounds When Retrofitting Facilities For ADCs 1/12/2026

    Antibody-drug conjugate manufacturing introduces significantly more risk to employees. Likewise, facility safety requirements are especially intense.

  7. Why Choose Robotic Processing For Small Batch Aseptic Filling 1/9/2026

    Reducing human intervention in aseptic filling is critical for safety and cost efficiency. Learn why automation is essential for small-batch applications and how it’s transforming sterile drug manufacturing.

  8. Increase Agility By Integrating Drug Substance And Drug Product 1/9/2026

    Biopharma success depends on agility. Move efficiently from discovery to delivery by co-locating drug substance and drug product operations, reducing transfer risks and accelerating your timeline

  9. Key Topics And Trends In Aseptic Filling 1/9/2026

    Aseptic filling is vital yet often guided by outdated practices. Discover expert insights on modern technologies, evolving regulations, and data-driven strategies to improve compliance and reduce risk in this critical manufacturing step.

  10. CDMO Checklist To Choose The Right Aseptic Isolator 1/9/2026

    Selecting the right isolator for aseptic filling requires more than comparing features. Discover essential questions to ask and make informed decisions that align with your process and operational goals.