Biosimilar White Papers

1. 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.

2. 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.

3. Business Continuity Management: The Benzonase® Endonuclease Success Story 8/21/2024

   Business continuity management is a key success contributor to the pharma industry. Explore best practices for a robust supply chain and how they can translate into success stories.

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. 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.

6. 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.

7. Perfusion Cell Line Development For Intensified Processes 5/5/2025

   The biopharmaceutical industry is transforming by shifting to continuous and intensified upstream bioprocesses, which are driven by evolving demands. Discover the key goals and innovations shaping this transition for modern healthcare.

8. 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.

9. 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.

10. 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.