Biosimilar White Papers

  1. ICH Q12 Updates: Increasing Efficiency Of Post-Approval Changes 4/2/2019

    Through proper implementation of ICH Q12 tools and enablers, the industry could manage CMC changes effectively under a company’s pharma quality system with less need for oversight prior to implementation.

  2. The Use Of Cell-Free Synthesis In The Future Of Modern Medicine 4/2/2019

    Cell-free synthesis systems are well suited to manufacture at the point of treatment, yet there are several challenges transitioning to this more efficient model for the future of medicine.

  3. Trends In Protein Separation And Analysis — The Advance Of Stain-Free Technology 4/7/2020

    Stain-free technology, a technology that existed in principle since early 2000 but was only commercialized in 2010 has changed the protein separation and analysis landscape in the past few years. This article focuses on how protein visualization is accomplished using stain-free technology, its advantages and concerns as well as how stain-free technology can change the way we carry out protein separation and analysis.

  4. The Role Of CDMOs In Cell And Gene Therapy Process Development 8/5/2020

    Even for experienced teams, it can be tricky to balance the efforts of reaching the first clinical trial using a manual, open method with building a more commercially suitable process. To accelerate their clinical and commercial programs, companies are choosing to work with contract development and manufacturing organizations (CDMOs). In this article, we highlight key areas where CDMOs can help companies get started in the world of CGT manufacturing. We also discuss when to engage with CDMOs to maximize commercial and clinical success.

  5. Strategies To Address The Viral Vector Manufacturing Shortage 3/5/2020

    Accelerating the production of your viral-vector based therapy requires understanding the strategies and cost-efficiencies available to address the viral vector manufacturing shortage.

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

    The supply chain and logistics for cell and gene therapies are especially critical to ensure the right patient gets the right treatment at the right time. Collaboration is the key to solving challenges such as data management and process variability, as stakeholders work towards a common goal—getting these life-saving treatments to the people who need them.

  7. Scaling A mAb Production Process To A Single-Use Platform 9/27/2019

    The transfer of mAb production processes between scales, referred to as scale-up or scale-down, is difficult. This study reviews moving mAb production from a microscale bioreactor to a single-use platform.

  8. LV Scale-Up Workflow In Single-Use Bioreactors For GMP Compliance 11/8/2019

    Cost-effective manufacturing of lentiviral vectors (LV) at commercial scales has proven difficult and remains a pressing issue for the marketing of therapies that depend on their application.

  9. 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.

  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.