Biosimilar White Papers

  1. 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.

  2. 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.

  3. Considerations For Improving Outcomes In Biopharmaceutical Process Development 8/12/2020

    In this article, we take a look at how the biopharmaceutical process outcome can be improved by increasing the performance and robustness of the bioprocess workflow through a variety of critical aspects, different strategic approaches, and innovative tools and methods.

  4. QRM For Filter Integrity Testing: Complying With EMA's Future Annex 1 10/21/2020

    Quality Risk Management (QRM) is a systematic process for dealing with risks to the quality of a pharmaceutical product throughout its lifecycle. Although QRM is not new, the regulatory focus on QRM will increase with the arrival of Annex 1 of the EMA. Integrity testing of sterile filters is a key focus of QRM as it is a fundamental element of sterility assurance. This article points out the insufficiency of traditional QRM for filter integrity testing and advocates a comprehensive approach that allows the identification and avoidance of possible errors.

  5. Enabling Biologic Drug Delivery Of Volumes Beyond 1 mL 7/22/2020

    Delivery system manufacturers need to manage conflicting requirements and offer delivery solutions that balance performance, robustness, and usability while delivering higher volume or viscosity biologics.

  6. Single-Use Systems For Vaccine Manufacturing 10/29/2019

    Next-gen vaccines will leverage recombinant approaches and intensified single-use systems (SUS) to increase capacity at reduced costs, but SUS suppliers will need to overcome regulatory challenges.

  7. Increasing Productivity In Hydrophobic Interaction Chromatography 2/27/2020

    In this study, the hydrophobicities of newer generation Capto HIC resins were compared to Sepharose High Performance and Sepharose Fast Flow HIC resins.

  8. Using In-Line Sensors For Real-Time Control 9/28/2020

    There's a biopharma production shift from manual processes to automated intervention. This paper exemplifies the use of sensors for in-process control of upstream and downstream process parameters.

  9. Ensuring Consistency In The Supply Of Cell Culture Media 12/16/2020

    This paper describes a robust, global manufacturing network for cell culture media that supports capacity expansion to meet growing demand and ensure business continuity.

  10. Accelerate CHO Cell Characterization With The Blazar™ Rodent Panel: A Guide For Adoption 2/24/2021

    The development of the Blazar™ Rodent Panel allows biopharma to move away from traditional in vivo antibody production assays when characterizing cell banks of rodent origin used in the production of biologicals.