Biosimilar App Notes & Case Studies

  1. Epitope Binning: A Critical Step In Antibody Selection 1/31/2020

    Epitope binning immunoassays using surface plasmon resonance (SPR) can and should be deployed in the development of new potential drug candidates. This article discusses how SPR is used to characterize closely related “bins” of mAbs targeting the same epitope of the target protein and how the selection process is used to develop new vaccines, therapeutic antibodies, and diagnostic tools.

  2. Workflow For Primary Human NK Cell Isolation, Xeno-Free Expansion, Harvest, And Cryopreservation 8/30/2018

    Obtaining primary human NK cells at clinically relevant scale is challenging. Find out how you can generate 109 cells using a xeno‑free NK cell expansion and several automated and functionally closed unit operations, suitable for cGMP environments.

  3. 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.

  4. How Biogen Integrated PAT With End-To-End Supply Chain Transparency 10/2/2018

    To drive dependable critical process control requirements, Biogen explored novel strategies to increase process and raw material control and optimize communication of data throughout the supply chain.

  5. The Economics Of Biomanufacturing Strategies: Can You Afford Failure? 2/21/2020

    Prior to making critical strategy decisions, a small biotech company completed an economic evaluation of manufacturing options to ensure it was selecting the best fit for its drug development needs. 

  6. 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.

  7. Scale-Up Of CHO Cell Fed-Batch Cultures In HyClone ActiPro Medium Supplemented With Cell Boost 7a And 7b 2/21/2020

    This note compares cell growth and recombinant protein production of multiple Chinese hamster ovary cell clones when cultured in HyClone ActiPro basal medium and Cell Boost 7a and 7b feeding supplements.

  8. Can A Shared Biomanufacturing Facility Be The Answer To The Demand Forecasting Dilemma? 8/13/2018

    Using a shared biomanufacturing facility, a biomanufacturer can minimize its investment while mitigating the risks of demand uncertainty and maximizing time to market.

  9. 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. 

  10. Pulse Check: How To Assess Your In-House Biomanufacturing Capabilities 6/18/2018

    By checking the pulse of your organization, you can identify gaps and develop a plan for how to address them, so you can make the right decisions at the right time.