Biosimilar White Papers

  1. Quality Matters – SEC Analysis For Antibody Aggregates
    10/25/2019

    Size exclusion chromatography (SEC) is the go-to analytical method in the analysis of therapeutic protein drugs. This article describes the factors affecting the reproducibility of columns and how you can minimize column variation.

  2. Advances In Immunotherapy For Cancer
    11/29/2017

    Over the past decade, advances in oncology research have resulted in many new treatment options that include immunotherapies. This article examines these newer therapies in more detail.

  3. The Use Of Cell-Free Synthesis In The Future Of Modern Medicine
    4/2/2019

    Cell-free synthesis systems are well suited to manufacture at the point of treatment, yet there are several challenges transitioning to this more efficient model for the future of medicine.

  4. Protein Analysis With Size Exclusion Chromatography (SEC)
    2/20/2018

    This white paper presents fundamentals about analytical SEC and describes how our new-generation agarose-based SEC columns are used in analysis of biomolecules.

  5. Optimizing Drug Safety And Efficacy Of Complex Next-Generation Biologics
    9/11/2019

    Learn what challenges exist when developing biologic drugs to be efficacious but safe and how novel analytical techniques, like surface plasmon resonance, can help circumvent these issues and optimize development.

  6. Developing A Scalable Process For Adenovirus Manufacturing
    4/2/2019

    To address the growing need for speed and efficiency in viral vector manufacturing, GE developed a process for adenovirus manufacturing that not only meets regulatory requirements but is also scalable.

  7. Digital Manufacturing Of Biologics
    2/19/2019

    In addition to an explanation of digital manufacturing, this paper covers how it can improve the productivity and robustness of existing processes and facilities. 

  8. CMC Strategies For The Development Of A Bispecific Antibody Platform for Cancer Immunotherapy
    5/31/2019

    Bispecific antibody development presents many challenges in product expression, bispecific purification, product stability, and scale up of the manufacturing process. 

  9. Sensitive And Reproducible SPR-Based Concentration And Ligand-Binding Analyses
    3/27/2019

    Surface plasmon resonance (SPR) assays are used across the life cycle of a biopharmaceutical, from target identification, through CQA determination, development, and on-going quality control. This article focuses on concentration assays associated with late-stage development and biotherapeutic drug chemical manufacturing and control.

  10. A Plasma Problem: Dwindling Supply In The Face Of A Growing Demand
    5/30/2019

    An outlook on the market shows plasma fractionators will have to look to innovation and other opportunities for supply, in order to meet the needs of patients.