Laboratory Services
Navigating Analytical Requirements for GMP Viral Vectors
Laboratory Service Offering
At Andelyn Biosciences, we are at the forefront of pioneering analytical methodologies that are integral to the success of gene therapy products.
Our expertise is pivotal in accelerating the trajectory of your product from the foundational pre-clinical phase right to the pivotal clinical trial stages. During the early phases of development, we offer tailored analytical development solutions and assistance with IND submissions, ensuring regulatory compliance and paving the way for successful transition into clinical trials. As your projects advance towards clinical manufacturing, we provide advanced analytics focusing on strategic DMF support, ensuring your journey into human trials is not only compliant but also strategically poised for success.
At Andelyn Biosciences, the thoroughness of our analytical development underpins our commitment to advancing gene therapy, ultimately ensuring the highest quality, safety, and efficacy of our products for those who depend on them the most.
Facilities Driving Innovation and Breakthroughs
Explore the cutting-edge environments where innovation and quality meet. Andelyn Biosciences proudly operates three specialized facilities, each designed to support different stages of gene therapy development and manufacturing. Discover how our advanced infrastructure and strategic locations contribute to accelerating your path to market.
Analytical Development
The stringent analytical requirements for viral vectors in gene therapy are crucial for ensuring product integrity and adherence to regulatory standards. Our promise of first-rate analytical testing and unfaltering regulatory adherence is not simply an assurance but a guarantee.
Quality Control
Working in synergy with the Analytical Development group, our 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. Each assay created by the Analytical Development team is first deployed in R&D quality control and must surpass stringent regulatory scrutiny prior to being operationalized within our GMP Quality Control domain. This structured approach reinforces not only our industry-leading position but also our dedication to being a trusted partner in pharmaceutical development.