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. 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.

3. A Comprehensive Solution For Adventitious Agent Testing 2/13/2026

   Modern sequencing methods offer sensitive detection of adventitious and species‑specific viruses. Learn how targeted and non‑targeted NGS approaches improve confidence in cell bank characterization.

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. Solve ATMP Aseptic Filling Challenges With Gloveless Isolators 1/9/2026

   Human intervention is the top contamination risk in ATMP manufacturing. Robotic gloveless isolators address that risk through full automation and real-time monitoring during aseptic filling.

6. 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.

7. 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.

8. 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.

9. ADC Development Grows More Complex — SPR Insights Bring Clarity 4/14/2026

   Explore how real-time kinetic analysis reveals how conjugation, linker chemistry, and drug loading influence antibody–antigen interactions, while enabling sensitive detection of anti-drug antibodies.

10. Life Cycle Assessment Of Extended Use Strategies For Single-Use Assemblies 4/17/2026

    Examine how extending the use of single‑use assemblies can significantly reduce emissions, resource consumption, and waste in bioprocessing, offering a data‑backed path toward sustainability.