Biosimilar White Papers

  1. 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.

  2. Standardizing Vein-To-Vein Logistics To Reach More Patients 2/24/2020

    Collaboration is  key to solving data management and process variability challenges as stakeholders work towards a common goal—getting life-saving treatments to those who need them.

  3. Developing TIL Therapies: Sample Collection And Processing 7/16/2020

    While it has been advanced over many years, the process of developing TIL therapies still suffers from certain challenges. This article attempts to lay bare some of these challenges and discuss how novel technological solutions can help overcome them.

  4. Viral Clearance: The Basics On How To Conduct Effective Studies 5/17/2019

    Effective viral clearance studies remain one of the challenges facing manufacturers of biologics. These studies are an essential part of process validation and are critical to ensure drug safety. This article provides the basics of what you need to know when studying virus reduction of a chromatography step.

  5. Developing A Scalable Process For Adenovirus Manufacturing 4/2/2019

    To address the growing need for speed and efficiency in viral vector manufacturing, Cytiva developed a process for adenovirus manufacturing that not only meets regulatory requirements but is also scalable.

  6. 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.

  7. 2D And 3D Pre-Designed Solutions For Storage And Shipping 3/18/2019

    Single-use in cGMP production requires enhanced assurance of supply and product performance. Innovative bioprocessing bag technology meets these challenges for every process step and application.

  8. 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.

  9. Meeting The Process Development Challenges Of A Diverse Biologic Pipeline 9/10/2020

    The biopharmaceutical industry has been growing and evolving at a pace that’s hard to match, especially in terms of manufacturing. Understanding what challenges diverse molecules can create and how to manage these challenges is key to ensuring they reach patients safely and efficiently.  

  10. Cell Therapy Scale-Up Strategies For Commercial Success 9/30/2020

    This article discusses options for cell therapy process development and validation that minimize risks through quality control (QC), optimization, scaling, closing, automation, and assay development.