Bioprocessing Application Notes & Case Studies

  1. A Single-Use Clinical Scale Filling System: From Design To Delivery

    Behind the scenes as Merck & Co. adds the capability to use a single-use filling wetted path, including single-use needles, in its clinical manufacturing facilities for finished drug products.

  2. Advanced Filtration Optimizes Blow Fill Seal Process For High Viscosity Formulation

    This case study shows how optimizing the filtration processes removed a bottleneck that, among other things, diminished product yields

  3. Pfizer Collaborates to Accelerate Approval of Biosimilar MAbs in China

    As Pfizer began its pursuit of delivering two biosimilar monoclonal antibodies (mAbs) in China, it sought a partner that could mitigate the risks of expanding into this region while also significantly reducing the development timeline. By leveraging the expertise of an experienced partner and the benefits of single-use technology (SUT), Pfizer was able to quickly establish a global footprint while also gaining a competitive advantage in an emerging market.

  4. Quick Purification Strategy: Adenovirus Purification

    Adenoviruses are commonly used as gene transfer vectors in gene therapy and clinical trials. However, their large size, complexity, and acid labile nature lead to challenges in their downstream purification.

  5. Pall Helium Integrity Test (HIT™) Technology for Allegro™ 2D Single-Use Systems

    Cutting edge supplier integrity test for single-use systems implemented in critical processing steps of drug substance or drug product, to enhance patient safety.

  6. How To Select The Right Filter Integrity Test Instrument

    A helpful set of criteria to help you compare and evaluate the features of the best-in-class integrity test instruments and to make informed choices.

  7. pH Sensor Recalibration Based On Exhaust CO2 Concentration For Bioprocess Transfer And Scaling

    Explanation of a method that allows effectively matching of the starting pH of carbonate-buffered systems in process transfers, scale up and scale down; cross plants, sites, and scales.

  8. Genderless Sterile Connection Technology - Greater Sterility Assurance From Manufacturing To Use

    The approach to the design, development, and validation of a new sterile connector.

  9. Volume Reduction And Process Optimization With Cadence™ Inline Concentrator

    See how this solution not only provides additional capital savings but will also resolve potential manufacturing floor space limitations.

  10. Redox Potential Monitoring For Improved Anaerobic Fermentation

    Understand the suitability of the BioFlo 120 control station equipped with BioBLU 3f Single-Use Vessels for anaerobic fermentation.