Andelyn Biosciences
Andelyn Biosciences specializes in the development and production of viral vectors for gene therapy, supporting global clinical trials and offering comprehensive manufacturing services.
Services
Andelyn Biosciences specializes in the development and production of viral vectors for gene therapy. The company offers a broad range of services, including plasmid manufacturing, process development, and GMP manufacturing. Their capacity supports both adherent and suspension processes, scaling up to 2,000 liters. The company provides manufacturing of research and toxicology grade viral vectors and plasmids that support preclinical studies, and also offers Phase I/IIa plasmid manufacturing.
Experience in Viral Vector Manufacturing
Andelyn Biosciences brings over 20 years of experience in manufacturing viral vectors. The company has produced GMP material for over 75 worldwide clinical trials and has successfully completed more than 450 cGMP clinical batches. This extensive experience underscores their capability and reliability in the field of gene therapy.
Process Development
Andelyn Biosciences employs rigorous process development guidelines, including process characterization and adherence to DoE (Design of Experiments) and QbD (Quality by Design) principles. The company supports clients through all phases of development and commercialization using their comprehensive digital model, quality system, full regulatory support, and supply chain vertical integration.
Adherent and Suspension-Based Manufacturing
The company provides an extensive range of viral vector and vaccine manufacturing services using both adherent and suspension-based processes. Their manufacturing capabilities are scalable up to 2,000 liters, supporting a variety of production needs from research-grade materials to clinical-grade batches.
