Biosimilar Manufacturing solution center

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Cell Culture Media Filtration: Evaluating Cell Culture Performance 10/23/2025

    Cell culture performance remained consistent across PES and PVDF filters, even under worst-case filtration conditions. Discover a practical framework for evaluating membrane impact on CHO cell growth.

  7. New Guide Aims To Build Robust Framework For Digital Validation Tools 10/22/2025

    The ISPE's new guide addresses software for managing digital assets related to qualification, verification, validation, and compliance assurance.

  8. Pfizer's Accord For A Healthier World Program Challenges Stability Study Norms 10/22/2025

    The company developed a novel approach to address the historic lack of stability testing for underserved parts of the world, near the equator.

  9. The 9 Fastest-Growing Outsourcing Segments 10/21/2025

    Capacity isn’t the choke point—capability is; this piece ranks nine fast-growing outsourcing segments and shows sponsors how to win by locking in modality-proven partners early.

  10. Takeda Reimagines Biopharma Quality For The Digital Age 10/21/2025

    Artificial intelligence, even in its current form, is especially good at synthesizing large data sets. Here's how one company makes the most of it.