Biosimilar App Notes & Case Studies

  1. Alkaline Stability Of Modern Protein A Chromatography Resins 7/12/2023

    Explore results from a resin lifetime study with over 150 cycles, using clarified cell harvest in every cycle, which has been performed to evaluate the alkaline stability of three protein A resins.

  2. Seamless Process Transfer Using An In Silico Bioreactor Scaling Tool 3/24/2025

    Transferring cell cultures between scales is challenging and error-prone. Discover a bioreactor scaling software that predicts optimal settings to enable efficient scale-up and progression to clinical studies.

  3. Aseptic Filling Solution Enhances Sterility Assurance for Pharma Manufacturer 11/21/2024

    Emergent BioSolutions upgraded its Winnipeg site with the Cytiva SA25 aseptic filling workcell to improve sterility assurance, product flexibility, and regulatory compliance for CGT manufacturing.

  4. Developing A Large-Scale Tangential Flow Filtration Process 5/13/2024

    Discover a process that can be modified to fit your downstream process and serves as a complete solution for concentration and diafiltration.

  5. Simplifying CHO Cell Line Genetic Stability Testing 4/11/2024

    Here, we describe the use of whole genome sequencing to perform a comprehensive assessment of genetic stability in clonally derived CHO cell banks using the Aptegra™ CHO genetic stability assay.

  6. Accelerating The Development And Optimization Of Cell Culture Media 10/18/2024

    Here, we outline the use of a microbioreactor for the rapid screening and optimization of media formulations for perfusion processes, and its role in predicting the performance of larger-scale bioreactors.

  7. Mobius® ADC Reactor Performance 10/22/2024

    Learn about a family of single-use ADC reactors that has been developed to offer a safer and more efficient ADC production method than traditional mixing systems and meet the industry's growing needs.

  8. Enabling Accelerated Raman Model Calibration For Real-Time Monitoring 6/14/2024

    Raman spectroscopy is a key component of a PAT strategy. Evaluate an innovative workflow designed to streamline the integration of an in-line Raman analyzer for bioreactor applications.

  9. Optimizing The Formulation For A Monoclonal Antibody 8/21/2023

    An emerging biotech company sought help developing a formulation for a monoclonal antibody. Explore how MilliporeSigma delivered an optimized formulation within an aggressive timeline and budget.

  10. Fab Fragment Development And Manufacturing For Clinical Trials 6/12/2024

    Explore the outcomes of implementing an accelerated approach to process development and manufacturing for a project that was crucial for the future of Acticor Biotech and its therapeutic candidate.