Biosimilar Manufacturing solution center

  1. A Second Reformation: Returning Biosimilar Regulations To Scientific Roots
    8/14/2019

    In light of BioApproval's Chris Webster’s recent publication and future presentation at the upcoming DIA Biosimilars conference, I spoke with him to learn more about the "Confirmation of Sufficient Likeness" approach and the scientific evidence that has informed this proposed biosimilar regulatory paradigm shift away from Totality of Evidence.

  2. Building A Better Film For Single-Use Bioprocessing Through Effective Partnering
    8/8/2019

    As the impact of extractables and leachables on product stability gained greater visibility in relation to single-use technology (SUT), GE Healthcare and Sealed Air formed a partnership to address the issues with the current film structures in today’s biopharma market. 

  3. Asia Bioprocessing Capacity Trends: Overall Growth, But Cell Therapy Shortages Loom
    8/8/2019

    Overall, the growth in Asia’s bioprocessing capacity, particularly in China, has been impressive, albeit from a low baseline. Capacity growth over the past five years has been over 20 percent annually. New facility construction and expansions reflect the demand for biologics for domestic consumption, while other facilities are beginning to develop manufacturing strategies for GMP production for major markets, with capacity involving commercial-scale stainless steel and single-use bioreactors.

  4. Purposeful Design And Development Of A Next-Generation Single-Use Bioprocess Film
    8/7/2019

    Fortem film development is an important investment by GE Healthcare, as it helps meet the industry need for a fully characterized platform film across all bioprocessing applications with supply chain transparency as a focal point. 

  5. FDA, USP Debate Standards: How Could This Impact Biosimilars?
    7/23/2019

    Even though the FDA has argued quite passionately against the need for biologics standards, there are several reasons why I hesitate to embrace their arguments that having these standards in place (and requiring they be met) could be harmful to biosimilars.

  6. Applications For Single-Use Systems In Biosimilar Development
    7/16/2019

    Exploring the benefits, challenges, and future of disposable systems in biosimilar manufacturing.

  7. The Debate On Standards In Biologics Development Heats Up
    7/11/2019

    Though it’s only natural to expect animated scientific discussion between the FDA and USP which have long been partners-in-science, I found myself caught off-guard by just how firmly the FDA has been putting its foot down and making its thoughts known on the role certain standards — in particular, USP monographs — should (or should not play) in biologics development.

  8. Securing Bioprocess Film Supply
    7/9/2019

    Learn how a partnership built on technical expertise and trust is helping to secure the supply of a single-use film built for bioprocessing.

  9. Viral Clearance: 7 Chromatography Column Considerations
    6/24/2019

    Viral clearance studies are a critical part of the production of biologics. However, performing studies that are accurate and cost-effective can be challenging. Here are seven things to consider while performing your next chromatography viral clearance study.

  10. USP Highlights Biosimilar Analytical Development Challenges, Possibilities
    6/19/2019

    During our conversation about the FDA’s most recent comparability guidance, I picked one USP expert's brain about the challenges of establishing a biosimilar analytical development program, as well as why certain types of data may be more difficult to come by than others. These challenges are responsible for further complicating the question about which types of data are still necessary, and why.