Biosimilar Manufacturing solution center

  1. Cell Culture Media Mixing In A Benchtop Single-Use Mixer 11/13/2025

    Explore how efficient powder-liquid mixing and sterile filtration preserve media integrity and support reproducibility in biopharmaceutical workflows, with promising scalability for larger-volume applications.

  2. Assessing Particle Generation In A Single-Use Mixing System 11/13/2025

    Explore how particle levels remained stable during 24 hours of high-speed mixing, even under extreme temperatures, confirming a system’s suitability for final fill and other particulate-sensitive applications.

  3. Viral Vector Technology Transfers: A Guide To Success 11/13/2025

    Strategic, well-aligned partnerships between sponsors and CDMOs are key to efficient, scalable viral vector technology transfer.

  4. Guidelines For Defining A Control Strategy Framework For Accelerated mAb Programs 11/6/2025

    This article assembles an industrywide “platform” knowledge base on the impact of parameters across unit operations in a standard mAb process. 

  5. Scale-Up Of A Transient rAAV Production Process 11/3/2025

    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.

  6. Scale-Up Of An Adherent rAAV Production Process 11/3/2025

    Fixed-bed bioreactors simplify the scale-up of viral vector production. Discover a system that bridges development and manufacturing with data confirming consistent performance across scales.

  7. A Simple Method For Cell Growth Media Preparation 11/3/2025

    Explore how powder media and sterile fluid handling can reduce contamination risk and improve efficiency in viral vector production, especially for HEK293-based AAV workflows.

  8. Exosome Production From hMSC Using A Fixed-Bed Bioreactor 11/3/2025

    Explore a high-yield, scalable process for hMSC-derived exosome production using fixed-bed bioreactors, with strong performance in purity, recovery, and biological activity.

  9. Process Validation: Working Toward Harmonization Of Terms Used To Identify Validation Lots 10/31/2025

    The terms “confirmatory" and "conformance" batches are inconsistently used in the industry. Since process validation is essential for maintaining compliance and detecting variability, we must work toward harmonization of the terms to avoid confusion.

  10. Dual Membrane Preconditioning Can Improve Concentration, Cut HCPs 10/27/2025

    Research from Penn State, the FDA, and Takeda shows how combination filtration and purification steps improve output and reduce impurities.