Biosimilar White Papers

  1. Manufacturing Challenges With High Concentration Biologics 3/18/2024

    Explore key process operations, some of the challenges in manufacturing high-concentration biologics, and factors to consider for process optimization.

  2. Establishing Analytical Methods For mRNA-Based Therapies 6/13/2023

    Here, we provide a detailed description of assays for sequence identification and LNP composition in mRNA-LNP products that support the development of safe and effective mRNA therapies.

  3. Digital Biomanufacturing, Now: From Digital Dreamer To Digital Doer 3/24/2025

    Discover how digital biomanufacturing is revolutionizing drug production by exploring strategies for integrating digital technologies to enhance efficiency, reliability, and innovation in bioprocessing workflows.

  4. Recommendations For Successful IND Approval Of RNA-LNP Drugs 8/22/2023

    The existing regulatory system is ambiguous for RNA therapeutics. Leverage this Investigational New Drug (IND) guide to help accelerate and strengthen the process IND filing of novel nanomedicines.

  5. A Supplier-Manufacturer Approach To Mitigating Nitrosamine Risk 10/10/2024

    Learn about how nitrosamines are formed, their prevalence and chemical precursors in pharmaceuticals, techniques for quantification, and approaches for managing nitrite impurities.

  6. Economic Advantage Of Robotic Gloveless Pharmaceutical Isolators 4/28/2025

    Are robotic gloveless isolators the key to smarter, safer, scalable solutions? Discover how they can revolutionize aseptic filling by reducing contamination, minimizing waste, and enhancing manufacturing flexibility.

  7. 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.

  8. Optimizing Safety Measures For rAAV Therapies 10/11/2024

    Explore common process-related impurities found in recombinant Adeno-Associated Virus (rAAV) vectors and the analytical testing methods used for these residuals.

  9. The Key To Accelerating RNA-LNP Drug Development 12/27/2023

    Learn about the drug development hurdles that must be overcome to deliver on the promise of mRNA.

  10. Five Essentials For Accurate Oligonucleotide Chemistry 3/4/2024

    Explore five key areas in oligonucleotide chemistry where improvements will have a huge influence on your synthesis quality.