Biosimilar App Notes & Case Studies

1. Reducing The Level Of Host Cell Proteins In The Bioreactor Harvest 10/20/2023

   Learn how MilliporeSigma helped a customer drastically reduce the level of HCPs in the bioreactor harvest prior to a production run to supply drug substance for a scheduled Phase 1 clinical trial.

2. Media And Buffer Mixing Using The Xcellerex™ Magnetic Mixer 6/19/2024

   A common requirement for media and buffer preparation in biopharma processing is powder-liquid mixing. Review the performance of a 3000 L single-use mixing system for preparing aqueous solutions.

3. Sterilizing Grade Filter Performance With Biologic Drugs 3/11/2024

   Examine the throughput performance of sterilizing grade filters across moderate-to-high concentrations of mAbs and immunoglobulins as well as how filter selection can impact your process.

4. Accelerate Process Development With Automated Aseptic Sampling 5/6/2024

   Discover how implementing automated sampling systems enabled Takeda Pharmaceuticals to achieve new efficiencies in process development.

5. 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.

6. Cell-Free Modeling Approach For Efficient Cell Culture Monitoring 6/14/2024

   Learn about a novel cell-free modeling method for the efficient monitoring of cell cultures that has significant advantages over traditional approaches.

7. 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.

8. Accelerating The mAb Formulation Process 5/7/2024

   Learn about a one-step process that was developed to streamline formulation, effectively reducing timelines from approximately 14 weeks to 8 weeks for this critical step.

9. Overcoming The Solubility Challenges Of Antibody-Drug Conjugates 6/3/2024

   Discover a chito-oligosaccharide that significantly improves the solubility of antibody-drug conjugates (ADCs) when included in the linker-payload construct.

10. 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.