Biosimilar Development insights

  1. 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.

  2. Cost Of Healthcare And Biopharma Implications
    6/11/2019

    The pharmaceutical industry’s success has become something of a double-edged sword, and our healthcare systems are burdened with the costs of lifestyle challenges. Everyday businesses and healthcare professionals must work diligently to improve our quality of life, but pricing and access will continue to be a battle globally that the industry must take note of.

  3. 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.

  4. 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.

  5. Stop Compromising Between High Yield And High Purity In Downstream Purifications
    6/5/2019

    Mixed-mode resins are often used when unimodal resins fall short of providing the required process productivity and/or process economics. To overcome this deficiency, Bio-Rad developed the Nuvia aPrime 4A Resin with an optimal balance of ion exchange and hydrophobic interactions to deliver simultaneous purity and yield of therapeutic proteins and monoclonal antibodies that are typically difficult to purify.

  6. A Model System For Fast Screening Of Optimal Protein Purification Conditions
    6/3/2019

    This study in an overview of a model system for screening optimal protein purification conditions on a mixed-mode cation exchange resin using a statistical software–generated design of experiment (DOE) model with ChromLab Software’s Multivariable Scouting (MVS) function on the NGC Chromatography System.

  7. Addressing New Chromatography Challenges With Fiber Adsorbents
    6/2/2019

    A new adsorbent material using a novel proprietary structure overcomes the diffusional and flow limitations of packed bed chromatography purification systems and also aims to address the capacity issues of chromatography membranes.

  8. The Current Landscape For Developing Biosimilars In India
    6/2/2019

    As India’s biosimilar market moves toward a promising future, it is important to gain an overview of the current regulatory and clinical expectations in India for biosimilar products.

  9. CMC Strategies For The Development Of A Bispecific Antibody Platform for Cancer Immunotherapy
    5/31/2019

    Bispecific antibody development presents many challenges in product expression, bispecific purification, product stability, and scale up of the manufacturing process; therefore, CMC strategies are critical for developing and marketing bispecific drugs. 

  10. A Plasma Problem: Dwindling Supply In The Face Of A Growing Demand
    5/30/2019

    An outlook on the market shows plasma fractionators will have to look to innovation and other opportunities for supply, in order to meet the needs of patients.