Biosimilar White Papers

1. 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.

2. 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.

3. 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.

4. 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.

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. 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?

7. A Shift Towards Biofluorescent Particle Counters In Manufacturing 5/12/2025

   Sterility in injectable drug manufacturing is vital for patient safety and efficiency. Discover how biofluorescent particle counters revolutionize contamination control, regulatory compliance, and operational excellence in modern pharma.

8. 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.

9. 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.

10. 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.