Biosimilar White Papers

  1. 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.

  2. 6 Regulatory Changes Affecting Bioprocessing In China
    4/2/2019

    This article outlines six recent regulatory changes in China intended to protect patient safety as well as reduce regulatory burdens and minimize delays.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  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. Virus Safety For Continuous Processing
    9/5/2019

    Transitioning to a continuous processing approach requires the implementation of an effective virus clearance strategy, which is intended to prevent various virus contaminations that could threaten patient safety.

  9. 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.

  10. 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.