Biosimilar App Notes & Case Studies

  1. 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.

  2. The Value Of A BD Integrated System For Combination Products 7/24/2020

    The growing complexity and regulatory rigour of combination products has called for increasingly innovative delivery devices. This article looks at the advantages of using an integrated system for these drug-device combination products rather than sourcing components from different suppliers.

  3. Purifying Plasmid DNA Using A Modern Chromatography Resin 2/5/2020

    Through an industry collaboration, Cobra and Cytiva were able to combine their expertise and experience and create a solution to meet the rising demand for high quality plasmid DNA.

  4. Cell Therapy Manufacturing Under GMP - How And When To Get Started 5/2/2019

    Emerging cellular therapies aim to manufacture cell populations for clinical indications, such as cancer, autoimmune, and cardiovascular diseases. As hospitals and translational facilities explore implementation of this technology they concurrently evaluate whether or not to manufacture the therapies onsite. Here is a guideline of how and when to get started.

  5. Developing A Closed Connected Single Use mAb Purification Process 9/28/2020

    This article provides an overview of a successfully designed closed and physically connected mAb process at the pilot scale with single-use components.

  6. Industry Trends In Clinical Development Technology 3/18/2020

    As electronic data sources become embedded in the clinical development process, systems, processes, files, storage, and approvals are moving away from paper and becoming application dependent.

  7. Robust Process Development For cGMP Manufacturing Of Cell Therapies 9/24/2020

    By leveraging early decisions around process development, quality assurance, and quality control strategies, you can set yourself up for a successful cGMP manufacturing workflow. 

  8. Quantitating Binding Similarities In IgG Fcγ Receptor Analysis 5/23/2019

    Critical quality attributes are fundamental to regulatory compliance in drug development and manufacturing. Learn how surface plasmon resonance has been applied for protein characterization of antibody effector function.

  9. Automated Glucose Control 7/9/2019

    This application note documents an example method for establishing glucose feed control and highlights the key benefits of applying said method to other processes. 

  10. Adenovirus Production In Single-Use Bioreactor System 3/8/2019

    Rocking bioreactor systems can shorten the seed train prior to inoculation and provide optimized growth conditions for sensitive cells. This study presents a robust production of adenovirus using such a system.