Biosimilar White Papers

1. 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.

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. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. Process Analytical Technology In The ADC Bioconjugation Process 4/23/2025

   Integrating Process Analytical Technology into validated GMP processes is complex and costly, which requires thorough validation of equipment and cleaning methods. Explore more about PAT's role in ADC production.

9. Optimizing Safety Measures For rAAV Therapies 10/11/2024

   Explore common process-related impurities found in recombinant Adeno-Associated Virus (rAAV) vectors and the analytical testing methods used for these residuals.

10. Achieve Higher Targeted Concentrations 9/30/2025

    Single-pass TFF streamlines downstream processing by reducing footprint, shear exposure, and hold-up volumes. Learn how this approach is advancing efficiency across therapeutic and vaccine production.