Elevate Your Standards with Andelyn's Quality Control
Philosophy and Approach
Our Quality Control (QC) approach at Andelyn Biosciences is rooted in a holistic philosophy that emphasizes integration across the product lifecycle. Recognizing QC as an integral part of both development and manufacturing, we closely align with analytical development and manufacturing, science and technology to ensure the highest standards of quality and consistency throughout every stage of production.
QC Capabilities
Our meticulous QC workflow ensures the integrity and quality of every product. From the initial assessment of critical materials to the final release testing, each step is carefully orchestrated to meet our stringent quality standards.
Rigorous inspection and disposition of critical materials.
Timely and precise testing at various production stages to monitor quality parameters.
Comprehensive analysis of finished products to verify conformity to specifications.
Long-term evaluation of product stability to ensure efficacy over time.
Ready to Take Quality to the Next Level?
Connect with our team today to discuss your quality control needs and discover how Andelyn Biosciences can support your journey towards excellence.
Quality Control
Our Quality Control augments our already robust commitment to regulatory compliance and quality assurance measures. This realignment involved the formation of complementary quality control and analytical development groups. The Quality Control team maintains an unwavering focus on GMP analytics, which are pivotal for the integrity of our clinical-phase productions, assuring manufacturing processes that are in strict accordance with the highest regulatory benchmarks.
Concurrently, the formation of our analytical development group signals our investment in continuous innovation. Their mandate crystallizes into three distinct yet synergistic directives: creating, developing and deploying essential assays; administering R&D quality control and testing across the breadth of our internal divisions, thereby ensuring that each developed assay meets or if possible, exceeds regulatory standards prior to being operationalized within our GMP QC domain.
Analytical Development
Our Analytical Development and Quality Control teams reinforce each other's efforts, ensuring rigorous quality standards from inception to release. With a focus on innovation and precision, our Analytical Development team pioneers advanced methodologies to support Quality Control initiatives. Explore how our integrated approach to analytical development and quality control enhances product quality and accelerates time-to-market.