Biosimilar White Papers

  1. Solve ATMP Aseptic Filling Challenges With Gloveless Isolators 1/9/2026

    Human intervention is the top contamination risk in ATMP manufacturing. Robotic gloveless isolators address that risk through full automation and real-time monitoring during aseptic filling.

  2. Achieve Higher Targeted Concentrations 9/30/2025

    Single-pass TFF streamlines downstream processing by reducing footprint, shear exposure, and hold-up volumes. Learn how this approach is advancing efficiency across therapeutic and vaccine production.

  3. Optimizing Safety Measures For rAAV Therapies 10/11/2024

    Explore common process-related impurities found in recombinant Adeno-Associated Virus (rAAV) vectors and the analytical testing methods used for these residuals.

  4. Performance Characteristics Of The Mobius® ADC Reactor For Conjugation 10/22/2024

    Explore results from a series of studies evaluating the mixing performance of an innovative ADC reactor during the conjugation step utilizing a model fluid.

  5. Is Sustainability The Key To Agile Biopharma Manufacturing? 3/18/2025

    In biologics manufacturing, change is constant. Discover how new innovations and a focus on sustainability have gotten 62% of executives to prioritize eco-friendly practices, which reflects a commitment to long-term viability.

  6. A Comprehensive Solution For Adventitious Agent Testing 2/13/2026

    Modern sequencing methods offer sensitive detection of adventitious and species‑specific viruses. Learn how targeted and non‑targeted NGS approaches improve confidence in cell bank characterization.

  7. The Role Of Extractables Data In The Adoption Of Single-Use Systems 8/29/2024

    Explore guidance for evaluating single-use systems for extractables and leachables, and learn how supplier-provided single-use system extractables data can save both time and resources.

  8. Regulatory Considerations For Excipients Used In Lipid Nanoparticles 8/15/2024

    Review the regulatory classification of LNPs, liposomes, and novel excipients as well as specific requirements outlined in regulatory guidance documents and strategies to navigate emerging challenges.

  9. Aggregation In Antibody-Drug Conjugates: Causes And Mitigation 9/1/2025

    Discover how early intervention in ADC development can streamline clinical progress, ensure stability and safety, and accelerate commercialization with expert guidance.

  10. Digital Biomanufacturing, Now: From Digital Dreamer To Digital Doer 3/24/2025

    Discover how digital biomanufacturing is revolutionizing drug production by exploring strategies for integrating digital technologies to enhance efficiency and innovation in bioprocessing workflows.