Biosimilar App Notes & Case Studies

  1. Balancing Stainless, Single-Use, And Continuous Manufacturing 9/21/2018

    Several drivers affect how the appropriate facility design and unit operations for a process are selected, making it imperative to properly evaluate each option. 

  2. Effects Of Feeding Strategy On CHO Cell Performance In Fed-Batch Cultures 2/21/2020

    This app note demonstrates a fed-batch process for a CHO cell line producing a mAb. The results emphasize the importance of an appropriate feeding strategy to optimize cell growth and productivity.

  3. EDGE Confocal Imaging Technology 10/9/2019

    Increasingly, scientists are being challenged to study more biologically-relevant model systems, and this often means imaging thick, demanding 3D samples that may also be alive. Read how IRIS and EDGE confocal imaging can offer high contrast imaging of thicker samples.

  4. Improved Process Economics Of Humira Biosimilar Purification 1/10/2019

    This application note proposes an alternate but equally effective approach to biosimilar purification, by substituting a less expensive ion exchange resin for the affinity capture step.

  5. Cell Therapy Manufacturing Under GMP - How And When To Get Started 5/2/2019

    Emerging cellular therapies aim to manufacture cell populations for clinical indications, such as cancer, autoimmune, and cardiovascular diseases. As hospitals and translational facilities explore implementation of this technology they concurrently evaluate whether or not to manufacture the therapies onsite. Here is a guideline of how and when to get started.

  6. Chromatography Resin Alternative For Capture Purification Of Antibodies 1/10/2019

    Protein A affinity purification has multiple limitations in terms of productivity at manufacturing scale and the costs associated with making commercial antibodies, especially biosimilars. 

  7. Automated High Throughput mAb Purification Using Fibro Technology 4/21/2020

    Biomanufacturing is trending towards higher numbers of monoclonal antibody (mAb) projects and smaller batch sizes, with production of most mAbs below 100 kg/yr. These trends are fueling demands to screen more clones faster and improve the efficiency of process development (PD). Read how the Fibro PrismA unit provides a time advantage with comparable recovery and product quality attributes to resin-based column.

  8. Making The Business Case For Vaccine Manufacturing 10/10/2018

    Vaccines are absolutely crucial for maintaining global health, but are a challenge to develop and manufacture. How can businesses ensure profitability while providing low prices for developing countries?

  9. Quantitating Binding Similarities In IgG Fcγ Receptor Analysis 5/23/2019

    Critical quality attributes are fundamental to regulatory compliance in drug development and manufacturing. Learn how surface plasmon resonance has been applied for protein characterization of antibody effector function.

  10. Purification Of Antibodies With Hydrophobic Anion Exchange Resin 9/11/2019

    A hydrophobic anion exchange mixed-mode resin has been developed to overcome challenges in antibody purification. This application note describes the purification of acidic and basic antibodies using this resin.