Biosimilar White Papers

1. 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.

2. 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.

3. Considerations For Developing The Recirculation/Perfusion Process 6/6/2024

   Learn about the recirculation and perfusion processes made possible by single-use, fixed-bed bioreactors designed for scaling up adherent cell culture processes.

4. 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.

5. Manufacturing Challenges With High Concentration Biologics 3/18/2024

   Explore key process operations, some of the challenges in manufacturing high-concentration biologics, and factors to consider for process optimization.

6. Revolutionizing Drug Discovery From "Undruggables" To AI 6/10/2024

   Explore four current trends in drug discovery, how each trend addresses some of the most crucial challenges in drug discovery, and the obstacles to their widespread adoption.

7. 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.

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. 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. 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.