Biosimilar White Papers

  1. The State Of Plastics Recycling In BioPharma 8/9/2023

    Recycling plastics from biomanufacturing proves uniquely difficult due to circularity, quality, and infrastructure challenges. Nonetheless, change is underway. Learn how this change is being spearheaded by industry leaders.

  2. The Dynamic Regulatory Environment Of Drug-Device Combination Products 11/29/2022

    Examine the dynamic regulatory environment of drug-device combination products as well as concrete steps to take to navigate regulatory complexities and decrease time to market.

  3. Sterile Filtration And Quality Risk Management 8/31/2023

    Process control is essential for manufacturing sterile products. Explore the role of filtration for bioburden control in quality risk management and contamination control strategies.

  4. Remote Access And Monitoring Of Bioprocess Unit Operations 5/26/2022

    Digital transformation projects require a scalable connectivity solution for the manufacturing floor that is easily and rapidly deployed. Explore elements that enable connectivity among equipment.

  5. Single-Use Multi-Layer Film Delivers Comparable Cell Growth Performance To Glass 5/12/2023

    Explore the findings of studies analyzing the performance of upstream bioprocessing with Ultimus® film, a single-use, multi-layer film with a fluid contact layer free of Irgafos® 168.

  6. Optimizing Lipid Formulations For Targeted RNA-LNP Applications 9/13/2022

    Learn about the considerations and challenges of using ionizable lipids, including the 5 types of lipids used for RNA delivery.

  7. Revolution In The EU Pharmaceutical Legislation Ahead 2/8/2024

    Discover the impact revised pharmaceutical legislation will have on the industry by superseding regulations that have fostered the availability of safe and effective medicines for the past two decades.

  8. Inspection Of Injectable Products For Visible Particulates 8/8/2023

    Examine the risks posed by particulates, the potential sources and types of particulates, and approaches to detect and measure visible particulates in injectables.

  9. Orthogonal Methods To Understand And Define CQAs Of AAV Therapies 2/24/2023

    An essential part of AAV vector production is the characterization of potential CQAs. Learn about novel, robust, and orthogonal methods that can be used to assess identity, purity, and residuals.

  10. Outstanding Sensitivity For Confident SPR Interaction Analysis 7/20/2022

    Explore how surface plasmon resonance (SPR)-based analyses with a high sensitivity instrument can provide greater data precision and better confidence in your results interpretation.