Biosimilar App Notes & Case Studies

31. 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.

32. Lentiviral Vector Production Using Single-Use Bioreactors 5/6/2024

    Here, we outline a scalable and robust upstream process developed for LVV production of HEK293T cells and demonstrate how to expand HEK293T suspension cells.

33. 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.

34. Automated Cell Washing And Formulation In CAR T Cell Therapy Manufacturing 6/14/2024

    Explore data collected from a study utilizing healthy donors in a typical CAR T cell processing workflow without a transduction step from a cross-site validation study.

35. Performance Of Mobius® Bag Assemblies With Ultimus® Film In Truck Shipping Simulation Test 10/29/2024

    Explore findings from a study testing Mobius® single-use bags under rigorous shipping conditions, demonstrating the suitability for transporting various liquid volumes while preserving their integrity.

36. 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.

37. 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.

38. 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.

39. 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.

40. 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.