Biosimilar App Notes & Case Studies

  1. Bulk Filling Of Drug Substance | Accurate Aliquoting 4/24/2024

    Bulk filling drug substances in traditional facilities is often a lengthy, manual process where operators are relied upon to adjust pump controls to achieve accurate filling. This method, spanning multiple shifts, increases process risk through errors that can compromise accuracy.

  2. Monitoring Bioprocesses In A Light Environment Using Raman Spectroscopy 6/14/2024

    Discover an advanced solution to facilitate the implementation of Raman technology at both laboratory and manufacturing scales in a normal light environment.

  3. An Innovative Approach To Streamline Raman Implementation 6/14/2024

    Standard methods for building Raman spectroscopy models are often time-consuming and resource-intensive. Explore one-batch calibration and how its performance compares to other modeling techniques.

  4. Getting CMC Right For Emerging Technologies 12/20/2023

    Establishing a chemistry, manufacturing, and controls strategy that proves a clinical program is tightly controlled and can address risk is critical to avoiding the pitfalls that stall many promising therapeutics.

  5. Integrated Services For Cell Line Preparation And Storage 10/8/2024

    Explore a comprehensive suite of services for the manufacture, characterization, and storage of cell banks as well as the advantages of working with an experienced partner.

  6. 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.

  7. Developing A HIC Polishing Step For The Removal Of mAb Aggregates 9/28/2023

    Learn in-depth about the development of a flow-through polishing step that employs hydrophobic interaction chromatography for the elimination of monoclonal antibody aggregates.

  8. 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.

  9. Selecting A Platform Filter For High Concentration mAbs 4/9/2025

    Read more about how Fujifilm Diosynth Biotechnologies evaluated a prime filter with challenging simulant solutions and how the experimental data confirmed superior performance, which demonstrated twice the throughput.

  10. Optimizing TFF And SPTFF For High-Concentration mAb Formulations 4/9/2025

    Discover the critical role of formulation buffer composition in stabilizing monoclonal antibodies during tangential flow filtration, a process involving ultrafiltration and diafiltration under high pressure and shear forces.