Biosimilar White Papers

  1. 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.

  2. 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.

  3. A Shift Towards Biofluorescent Particle Counters In Manufacturing 5/12/2025

    Sterility in injectable drug manufacturing is vital for patient safety and efficiency. Discover how biofluorescent particle counters revolutionize contamination control, regulatory compliance, and operational excellence in modern pharma.

  4. Biologics Technology Transfer Guidebook 2/26/2025

    Explore why technology transfer is a critical component in mammalian biologic drug development and manufacturing with the essential guide to biologics tech transfer that covers key strategies, best practices, and critical considerations.

  5. 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.

  6. The Role Of Extractables Data In The Adoption Of Single-Use Systems 8/29/2024

    Explore guidance for evaluating single-use systems for extractables and leachables, and learn how supplier-provided single-use system extractables data can save both time and resources.

  7. 2024 Global Biopharma Sustainability Review 9/3/2024

    What steps is the biopharma industry taking to enhance sustainability? What challenges does biopharma encounter? And how can the entire industry draw lessons from the companies setting the standard?

  8. Advancing A LNP Formulation To Clinical And Commercial Manufacturing 3/25/2024

    Lipid selection impacts the final LNP drug product and the LNP process. Review critical quality considerations for lipids and the process requirements for successful commercial-scale manufacturing.

  9. Innovation In Filtration 3/18/2025

    Filtration removes contaminants to ensure safety and is essential in various applications, from lab-scale tasks to GMP production. Explore how its simplicity and reliability make it indispensable.

  10. COGs Process Economics For Autologous Cell Therapy 8/11/2023

    Analyze the cost distribution over time for autologous CAR T therapy manufacturing using process economics and additional insights. Discover how cell therapy manufacturers can combat these costs.