Biosimilar App Notes & Case Studies

  1. 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.

  2. Introducing N-1 Perfusion To Intensify The Seed Train At A Higher Starting Density 5/13/2021

    A high-density N-1 seed culture can improve your fed-batch process by allowing you to seed the production (N) bioreactor at a higher starting density or to replace a large N-1 bioreactor.

  3. Upstream Platform For Continuous Lentiviral Vector Production 12/1/2020

    Process scalability, lot-to-lot consistency, and the cost and supply of high-quality plasmid are some of the constraints that have made manufacturing of LVs challenging. Here, we demonstrate a high-yield LV production process, using animal-derived component-free (ADCF) media and reagents, where multiple or continuous vector harvests could be obtained from a single batch.

  4. Purifying Infectious Virus Particles Using ÄKTA™ Start 5/20/2021

    Making it easier to purify virus particles can help accelerate developments in virology. This application note demonstrates a chromatography method for purifying reovirus RNA virus particles using ÄKTA™ start, our benchtop chromatography system, and HiTrap™ brand columns with Capto™ brand Core 700 resin.

  5. High-Quality Chromatography System Meets Predesigned DeltaV For Integrated Manufacturing 3/9/2021

    Cytiva’s pre-defined automation solution, Figurate™️, is now available as a turnkey solution by combining our industry-leading ÄKTA™️ process chromatography system with the reliability of the DeltaV DCS platform.

  6. Achieving Business Continuity In Pharma During COVID-19 Restrictions 3/4/2021

    To ensure business continuity during COVID-19 restrictions, we developed a virtual factory acceptance testing solution that allowed SaudiVax to advance their manufacturing plan.

  7. Pluripotent Stem Cell Expansion And Scale-Up 8/5/2020

    Upstream process development is complex for stem cell therapies, because these therapies involve many manipulations during cell differentiation or even cell engineering. Decisions made early in research will impact the entire product life cycle, so it is important to consider a good process design early on.

  8. 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.

  9. Identifying New, Enhanced Device Delivery Solutions For Chronic Diseases 7/26/2021

    Needle innovations, including the usage of shorter needles with ultra-thin wall technology for prefilled syringes, support the delivery of drugs with greater volumes and viscosities, which greatly enhances end-user experience.

  10. Regulatory Challenges For Viral Vectors For Cell And Gene Therapy 7/24/2020

    Frost & Sullivan's Virtual Think Tank series brought together leading minds in the cell & gene space to discuss current regulatory issues and key challenges in viral vector manufacturing.