Biosimilar White Papers

1. ADC Manufacturing: Practices, Challenges, And The Road Ahead 6/15/2026

   ADCs are advancing quickly, but manufacturing complexity is rising just as fast. Key challenges in scale-up, regulation, and costs are reshaping how the next generation of therapies will be delivered.

2. 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.

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. 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.

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. 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.

7. 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.

8. Why Choose Robotic Processing For Small Batch Aseptic Filling 1/9/2026

   Reducing human intervention in aseptic filling is critical for safety and cost efficiency. Learn why automation is essential for small-batch applications and how it’s transforming sterile drug manufacturing.

9. Assessing A Targeted Molecular Method Against Traditional In Vitro Testing For Adventitious Virus Detection 10/3/2024

   Discover a CHO AOF panel that provides rapid detection of relevant adventitious viral contaminants in bulk harvest material, and explore data showing equivalent sensitivity to the in vitro assay.

10. 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.