Biosimilar Development insights

  1. 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, some of the questions to consider in order to map out a successful pathway and avoid pitfalls along the way.

  2. Modular Bioprocessing Alleviates Drug Manufacturing Woes
    4/4/2019

    Building a bioprocessing facility is usually a complicated process and requires partnering with not only drug developers, but also many different experts in various industries. BeiGene, a commercial-stage biotechnology company, can attest to these challenges.

  3. ICH Q12 Updates: Increasing Predictability And 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 pharmaceutical quality system with less need for extensive regulatory oversight prior to implementation.

  4. 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.

  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. 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.

  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. 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.

  9. Cell Therapy Manufacturing: The Supply Chain Challenge
    4/1/2019

    Overcoming the challenges of manufacturing and administering a complex product to any patient is critical for delivering cell therapies. Here two industry experts provide practical advice on strategies to meet supply chain challenges.

  10. Converting From ELISA To Biacore SPR Assays
    3/27/2019

    Biacore SPR assays provide an automated and reproducible real-time determination of active concentrations that can be considered an alternative to traditional ELISA approach. This article provides general guidance on how to convert an existing ELISA assay to a Biacore SPR-assay and by doing so, shows how you can get results in less than half the time compared with ELISA.