Biosimilar White Papers

1. Bio-Based Polymers Towards Net Zero In Single-Use Bioprocessing 6/13/2025

   Decarbonizing healthcare and pharmaceuticals is vital to meet climate goals and safeguard public health. Learn why these energy-intensive sectors must act swiftly to reduce emissions and navigate complex global supply chains.

2. Considerations For Developing The Recirculation/Perfusion Process 6/6/2024

   Learn about the recirculation and perfusion processes made possible by single-use, fixed-bed bioreactors designed for scaling up adherent cell culture processes.

3. Establishing Commercial Manufacturing Services For ADCs 6/3/2024

   Explore how one organization built upon 15+ years of experience and an extensive knowledge base of biologics manufacturing to establish commercial-scale ADC manufacturing capabilities.

4. 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.

5. Performance Characteristics Of The Mobius® ADC Reactor For Conjugation 10/22/2024

   Explore results from a series of studies evaluating the mixing performance of an innovative ADC reactor during the conjugation step utilizing a model fluid.

6. 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.

7. The Advantages Of A Blended Learning Approach In Operator Training 5/30/2024

   Explore blended learning and its advantages over traditional operator training methods, which often reduce training to a repetitive but necessary checklist of reading and acknowledging procedures.

8. Regulatory Considerations For Excipients Used In Lipid Nanoparticles 8/15/2024

   Review the regulatory classification of LNPs, liposomes, and novel excipients as well as specific requirements outlined in regulatory guidance documents and strategies to navigate emerging challenges.

9. 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.

10. Perfusion Cell Line Development For Intensified Processes 5/5/2025

    The biopharmaceutical industry is transforming by shifting to continuous and intensified upstream bioprocesses, which are driven by evolving demands. Discover the key goals and innovations shaping this transition for modern healthcare.