Biosimilar App Notes & Case Studies

  1. Purification Of Antibodies With Hydrophobic Anion Exchange Resin

    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

    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

    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

    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

    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

    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

    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

    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

    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

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