Aragen Capacity Update April 2025: Analytical Services

Join us for an insightful webinar titled "Innovative Analytical Solutions for Pharma and Biotech: Enhancing Drug Development with Aragen." This session is designed to showcase Aragen's cutting-edge analytical capabilities and expertise in addressing nitrosamine impurities, providing valuable insights for professionals in the pharma and biotech industries.

Analytical Solutions Capabilities: Aragen's analytical solutions are at the forefront of transforming drug development processes. Our state-of-the-art facilities, equipped with industry-leading instrumentation, enable us to offer a comprehensive range of services, including analytical method development and validation, stability testing, quality control, and release testing. Our team of over 120 analytical scientists, with diverse skillsets and extensive experience, ensures that we deliver high-quality, reliable results to support the rapid progress of customer drug candidates. Our capabilities span across various techniques such as chromatography, mass spectrometry, ion chromatography, and microbiology, all maintained under cGMP conditions and compliant with 21 CFR Part 11.

Nitrosamine Impurities: Nitrosamine impurities have become a significant concern in the pharmaceutical industry due to their potential carcinogenicity. Aragen's expertise in nitrosamine analysis includes risk evaluation, confirmatory testing, and GMP quantitative tests for high-risk products. Our advanced analytical equipment, including LC-MS/MS, GC-MS, and GC-MS/MS, allows us to detect and quantify nitrosamines with high sensitivity (LOQ: 0.2 ng/mL, LOD: 0.1 ng/mL). Our team of 35 scientists, experienced in handling regulatory audits, has successfully analyzed over 200 products for nitrosamine impurities, ensuring compliance with international standards.

Key Takeaways:

• Discover Aragen's comprehensive analytical solutions and how they can accelerate your drug development process.
• Gain insights into the latest advancements in nitrosamine analysis and risk mitigation strategies.
• Learn from real-world case studies and applications of our analytical capabilities.

Don't miss this opportunity to enhance your understanding of innovative analytical solutions and nitrosamine impurities.