Biosimilar App Notes & Case Studies

31. Alkaline Stability Of Fc And VH3 Binding In Protein A Resins 5/1/2023

    In this study, we looked at how different antibody binding sites of a protein A ligand are affected by cleaning in place (CIP).

32. 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.

33. 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.

34. How To Protect A Modern Silicone Oil-Sensitive Biologic Drug For Self-Injection Of 2.25mL 4/25/2023

    A customer experienced expensive project delays when they selected their “tried and tested” large volume, glass syringe system to package a drug to be used in an auto-injector for self-administration.

35. 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.

36. 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.

37. Using Automated Spinoculation For CAR T Cell Lentiviral Transduction 2/26/2024

    There is a growing demand for closed and automated lentiviral transduction steps in CAR T cell therapy workflows. Learn about a potential solution to address this unmet need.

38. The Use Of Injectable Packaging From Early Development To Commercialization 2/20/2024

    While in their early-stage development of a mAb biosimilar for oncology treatment, a large biopharmaceuticals company sought a packaging recommendation: a stopper to maintain high-quality standards.

39. TFF For Laboratory And Process Development Applications 3/1/2023

    Learn about the basic principles that govern tangential flow filtration (TFF) along with the use of TFF capsules and cassettes in laboratory and process development applications.

40. Review Of Applications And Processes In Fixed-Bed Bioreactors 5/6/2024

    Gain insights and guidelines for developing new processes in this review evaluating publications on the applications of single-use, scalable fixed-bed bioreactors for adherent cell culture processes.