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. 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.

  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. Manufacturing Of Sterile Aqueous Suspensions: A Primer 5/14/2018

    Sterile suspensions are particularly difficult to manufacture. This technical article covers factors for success, including particle size, vehicle formulation, and considerations for high-shear mixing. 

  5. Scaling A mAb Production Process To A Single-Use Platform 9/27/2019

    The transfer of mAb production processes between scales, referred to as scale-up or scale-down, is difficult. This study reviews moving mAb production from a microscale bioreactor to a single-use platform.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.