Biosimilar White Papers

1. A Risk-Based Approach To Plasmid DNA And mRNA Process Development 9/23/2025

   Balancing robust analytics and clinical readiness is key for early-phase pDNA and mRNA therapeutics amid structural complexity and regulatory challenges.

2. 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?

3. How Lipid Nanoparticles Enable Next-Gen Delivery 10/20/2025

   Cell therapy’s future depends on smarter gene delivery. Learn how lipid nanoparticles offer a scalable, cell-friendly alternative to electroporation and viral vectors for manufacturing efficiency.

4. Aseptic Process Design And Simulation Under Annex 1 Guidelines 1/9/2026

   Gain insight into how Annex 1 reshapes aseptic process validation, as well as into risk reduction by design and why isolators are redefining modern sterile manufacturing standards.

5. 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.

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. Aggregation In Antibody-Drug Conjugates: Causes And Mitigation 9/1/2025

   Discover how early intervention in ADC development can streamline clinical progress, ensure stability and safety, and accelerate commercialization with expert guidance.

8. Biopharma Supply, Reimagined: Regional, Resilient Manufacturing 4/1/2026

   Persistent disruption is redefining biopharma supply chains. Explore how regional manufacturing, integrated risk management, and closer collaboration help build resilience and improve agility.

9. 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.

10. 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.