Biosimilar White Papers

  1. Addressing New Chromatography Challenges With Fiber Absorbents
    6/2/2019

    An absorbent material using a novel proprietary structure overcomes the diffusional and flow limitations of packed bed chromatography purification systems and aims to address the capacity issues.

  2. More Efficient Bispecific Antibody Purification With Fewer Steps
    2/28/2019

    A single-step downstream process using protein A chromatography to purify a bispecific antibody (BsAb) in early screening has been successfully developed to replace an existing-three step process.

  3. 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.

  4. 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.

  5. 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.

  6. Benefits And Challenges Of Driving Modernization In Vaccine Development
    6/11/2019

    Protein Sciences learned several valuable lessons during the development and final regulatory approval of its recombinant hemagglutinin (rHA) influenza vaccine, Flublok.

  7. 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.

  8. Bioburden: Address Microbial Contamination In Downstream Bioprocessing
    8/30/2017

    A discussion on the risks related to bioburden downstream processing and ways to mitigate them. Topics covered include improvements in raw material, equipment design, and chromatography resin properties.

  9. ICH Q12 Updates: Increasing Efficiency Of Post-Approval Changes
    4/2/2019

    Through proper implementation of ICH Q12 tools and enablers, the industry could manage CMC changes effectively under a company’s pharma quality system with less need for oversight prior to implementation.

  10. A Common Sense Approach To Sustainability In The Biosimilar Business
    4/2/2019

    Through common sense and creative thinking, the industry can discover new ways to achieve success and sustainability in the biosimilar market.