Biosimilar App Notes & Case Studies

31. 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.

32. 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.

33. Adapting Single-Use Chromatography To Manufacturing Scale 5/16/2024

    Explore strategies for accommodating the ever-increasing upstream titers and volumes to prevent downstream purification from becoming a bottleneck.

34. 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.

35. Accelerating Bulk Harvest Release Testing With A PCR-Based Solution 7/3/2024

    Adventitious agent testing is frequently a bottleneck in downstream processing. Discover a PCR-based solution for manufacturing processes using CHO cells and animal origin-free components.

36. Cell Retention Technology And Specialized Cell Culture Media 8/11/2025

    Explore how perfusion technology is transforming upstream bioprocessing by boosting productivity, reducing costs, and enabling process intensification while overcoming cell retention challenges.

37. Characterization Of Host Cell Proteins By Liquid Chromatography - Mass Spectrometry 2/26/2024

    Explore an established liquid chromatography – tandem mass spectrometry (LC-MS/MS) method for characterization of residual HCPs in monoclonal antibody (mAb) products.

38. 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.

39. Determining The Power Numbers For A Single-Use Mixing System 6/19/2024

    In designing a mixing process for scale-up, the power number is a critical parameter. Explore the determined power numbers for a single-use mixer at various mixing speeds and fill levels.

40. Extractables In Single-Use Systems Used In ADC Manufacturing 9/23/2024

    To address concerns about using organic solvents in the ADC process, extractables studies were conducted on a disposable chromatography column housing and two different disposable flow paths.