Biosimilar Development insights

  1. Multidimensional Scale-Up Of A Monoclonal Antibody Capture Step Contributes To Shortened Time To Market
    10/10/2018

    Fast and efficient process development and scale-up contributes to a shortened time to market. This application note demonstrates a multidimensional scale-up (change of both column diameter and bed height) of a mAb capture step, using the ÄKTA pilot 600 chromatography system.

  2. Process-Economy Simulation Of mAb Capture Step With Protein A Chromatography Resin
    10/10/2018

    Calculation examples that highlight scenarios where the enhanced capacity and alkaline‑stability of MabSelect PrismA can provide process economic benefits to large‑scale mAb processing.

  3. Efficient Cleaning-In-Place Methods For Protein-Based Antibody Affinity Chromatography Resins
    10/2/2018

    This whitepaper discusses cleaning of affinity resins intended for use in the purification of monoclonal antibodies and antibody fragments.

  4. Use Of Sodium Hydroxide For Cleaning And Sanitization Of Chromatography Resins And Systems
    10/2/2018

    This application note examines these aspects of using sodium hydroxide as a cleaning and sanitizing agent.

  5. Lifetime Performance Study Of MabSelect™ PrismA During Repeated Cleaning‑In‑Place Cycles
    10/2/2018

    A demonstration of the long‑term chromatographic performance of MabSelect PrismA during repeated purification cycles using 0.5 M NaOH for CIP.

  6. Capacity And Performance Of MabSelect™ PrismA Protein A Chromatography Resin
    10/2/2018

    This application note demonstrates the binding capacity of MabSelect PrismA in comparison with its predecessor products for both polyclonal and monoclonal antibodies.

  7. How Biogen Integrated Process Analytics Technology With End-To-End Supply Chain Transparency
    10/2/2018

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

  8. Facility Design — Balancing Stainless-Steel, Single-Use, And Continuous Approaches To Manufacturing
    9/21/2018

    Although change may be intimidating, disruptive innovation allows manufacturers to achieve increased efficiency and quality.  Several drivers affect how the appropriate facility design and unit operations for a process are selected, making it imperative to properly evaluate each option. 

  9. Purification Platform For IgMs
    9/21/2018

    Understand the challenges of IgM purification and how to design a scalable non-affinity based purification platform for manufacture of diagnostic IgMs

  10. Poster Review Non–Affinity Based Purification Platform for Neutral/Basic IgMs
    9/21/2018

    Review the biological properties of IgM antibodies that make them very effective vehicles for in vitro diagnostics and therapeutics.