White Papers

1. A Guide To Accelerating Cell Line Development For Commercial Production 7/11/2025

   Explore the challenges associated with cell line development in the production of biologics, and solutions that can help biotech developers evade the pitfalls of misinformed decision-making.

2. How To Adopt CSA For Streamlined Computer System Validation 7/1/2025

   Discover how the FDA’s Computer Software Assurance guidance modernizes validation by reducing compliance burdens and fostering innovation through a streamlined approach to system validation.

3. Ready To Demystify Organoids? 7/1/2025

   Organoids are transforming biomedical research. Explore their top applications, research workflows, key challenges, and dissociation techniques in this comprehensive guide to personalized medicine.

4. Optimal Microbial Sampling Criteria 6/24/2025

   Microbiological sampling ensures sterile conditions through surface, passive, and active air methods. The EU GMP Annex 1 emphasizes integrating these for comprehensive environmental monitoring.

5. Digital Maturity In Life Sciences Quality And Manufacturing 6/17/2025

   Innovators in life sciences manufacturing drive life-saving breakthroughs. Amid strict regulations and complex challenges, learn how your dedication ensures quality and pushes the boundaries of what’s possible in public health.

6. Bio-Based Polymers Towards Net Zero In Single-Use Bioprocessing 6/13/2025

   Decarbonizing healthcare and pharmaceuticals is vital to meet climate goals and safeguard public health. Learn why these energy-intensive sectors must act swiftly to reduce emissions and navigate complex global supply chains.

7. Biomanufacturing Readiness: A Validation Model For Multiproduct Facilities 6/12/2025

   Optimize your validation strategy to meet evolving regulatory demands and product complexities with a scalable, efficient framework that accelerates facility readiness and ensures consistent quality.

8. Preclinical Evaluation Of Vaccines And Antivirals In RSV Challenge Rodent Models 6/10/2025

   Here, we present multiple case studies utilizing clinically relevant mouse and rat models to evaluate key characteristics of potential RSV therapeutics.

9. Preclinical Evaluation Of New Antifibrotics In NASH-Induced Fibrosis Models 6/10/2025

   Accelerate the development of antifibrotic therapies through our clinically relevant models, deep scientific expertise, and proven preclinical capabilities in this area of unmet medical need.

10. Preclinical Evaluation Of Antifibrotics In COVID-Induced Fibrosis Model 6/10/2025

    Advancing the development of effective antifibrotic therapies requires urgent investment in clinically relevant, IND-enabling preclinical models to address the growing burden of fibrotic diseases.