Biosimilar White Papers

  1. 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.

  2. 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.

  3. 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.

  4. Process Effects On Drug Product Quality In Pharmaceutical Manufacturing—A Validated Measurement Process
    5/30/2019

    This whitepaper discusses the importance of understanding how critical process parameters can impact a product’s critical quality attributes, and how a systematic approach with validated SPR assays can help in this respect.

  5. Utilizing External Collaboration To Accelerate Vaccine Development
    11/2/2018

    Securing a partner to serve as an extension of Janssen’s Biotherapeutics Development API-Large Molecule team was essential to reduce both risk and the time needed for delivery of clinical supplies.

  6. Understanding And Controlling Raw Material Variation In Cell Culture Media
    9/5/2019

    An organized effort across biopharma, including drug substance manufacturers and suppliers, is needed to address and meet the needs of industry regarding raw material quality and consistency.

  7. Critical Considerations About The Future Of Global Cell Culture Bioprocessing
    4/2/2019

    In today’s changing industry, it is critical we consider several factors about cell culture bioprocessing and the impact they will have on the future of patient treatment.

  8. 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.

  9. 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.

  10. Guidelines To Bring Your Biologic To Market: Are You Prepared?
    4/16/2019

    Are you up to the task of bringing a biologic drug to market? Do you have a strategy and plan for moving forward? Here we explore, from a biopharma process development and manufacturing perspective.