Biosimilar App Notes & Case Studies

  1. 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 mixed-mode chromatography resin through bind-elute and flow-through modes of purification.

  2. Effect Of Buffer Composition On Protein Purification With A Hydrophobic Anion Exchange Resin, Nuvia aPrime 4A
    10/7/2019

    This study demonstrates that the use of buffer components have significant effects on the purity and recovery of target molecules during the purification step using Nuvia aPrime 4A, a hydrophobic anion exchange resin. 

  3. Prepare For An FDA Bioburden Inspection
    1/29/2018

    A former FDA Biologics License Application reviewer and inspector focusing on microbiology, shares expert tips on how to best approach a bioburden problem when an FDA inspection is imminent.

  4. 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.

  5. Converting From ELISA To Biacore SPR Assays
    3/27/2019

    Biacore SPR assays provide an automated and reproducible real-time determination of active concentrations that can be considered an alternative to traditional ELISA approach. This article provides general guidance on how to convert an existing ELISA assay to a Biacore SPR-assay and by doing so, shows how you can get results in less than half the time compared with ELISA.

  6. Modular Approaches For Diverse Molecules: Reinventing Smart Bioprocessing
    2/23/2018

    Smart bioprocessing uses bioinformatics, lab-scale processing, and analytics to create efficient and cost-effective production processes that can be verified at lab-scale before scale-up.

  7. Low-Cost, Fast, And Scalable Downstream Purification Process Development For A Clinical-Stage Retrovirus-Like Particle
    10/7/2019

    Purification of enveloped viruses and virus-liked particles presents several challenges due to their large size and complexity. This case study demonstrates resin screening, process development and scale-up purification of a retrovirus-like particle. 

  8. Improved Method for Determination of Adenovirus Concentration Using Surface Plasmon Resonance
    9/10/2018

    The performance of two assays for determination of adenovirus concentration based on surface plasmon resonance (SPR) is demonstrated in this application note.

  9. Amgen’s Digital Transformation: Link Suppliers' Raw Material Data To Patients
    10/19/2018

    Using its Supplier Relationship Excellence program, Amgen opened the lines of communication with suppliers and created a feedback loop where data can be shared to optimize operational performance. 

  10. Biosimilars: Providing More Treatment Options
    2/15/2018

    It is hoped that the development of biosimilars will lead to more competition, and therefore, more accessible, cost-effective treatments.