Biosimilar White Papers

  1. 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.

  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. 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.

  4. 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.

  5. 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.

  6. De-Mystifying And De-Risking Process Development Through Early Engagement With A CDMO 11/27/2018

    An overview of how CDMOs can help companies get started in the world of CGT manufacturing, with considerations around timing of engagement to maximize commercial and clinical success.

  7. Robust Field Guide To qPCR 4/9/2020

    qPCR remains the gold standard for validation of microarray and next generation sequencing data and the method of choice for both clinical and basic research labs for a wide range of applications. However, there remains general concern about the production of data that truly reflects the tested experimental conditions. We have developed a comprehensive guide to performing the ultimate qPCR experiment. The following is a snapshot of the critical steps needed to achieve excellent results.

  8. Development Pathways For ATMPs: Virus Safety Challenges And Regulatory Perspective 6/11/2019

    There is an increased risk of viral contamination in settings where ATMPs are prepared, making it critical to understand the contamination risks and the solutions available to control them.

  9. 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.

  10. 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.