Biosimilar White Papers

1. 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.

2. Is Sustainability The Key To Agile Biopharma Manufacturing? 3/18/2025

   In biologics manufacturing, change is constant. Discover how new innovations and a focus on sustainability have gotten 62% of executives to prioritize eco-friendly practices, which reflects a commitment to long-term viability.

3. 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.

4. 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.

5. 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.

6. The Evolution Of Antibody-Drug Manufacturing 6/3/2024

   Explore how ADC chemistry and manufacturing have evolved, the challenges this dynamic growth has created, and how CDMOs are adapting to these changes to meet customer needs, now and in the future.

7. Advancing A LNP Formulation To Clinical And Commercial Manufacturing 3/25/2024

   Lipid selection impacts the final LNP drug product and the LNP process. Review critical quality considerations for lipids and the process requirements for successful commercial-scale manufacturing.

8. 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.

9. Innovation In Filtration 3/18/2025

   Filtration removes contaminants to ensure safety and is essential in various applications, from lab-scale tasks to GMP production. Explore how its simplicity and reliability make it indispensable.

10. 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.