Andelyn Biosciences

Andelyn Biosciences' Expertise in Viral Vector Production

Andelyn Biosciences stands out in the biotechnology sector with its specialization in the development and production of viral vectors for gene therapy. With over 20 years of experience, the company has firmly established its reputation by producing GMP material for over 75 worldwide clinical trials and more than 450 cGMP clinical batches. This extensive experience underscores Andelyn Biosciences' commitment to advancing gene therapy solutions through rigorous and innovative manufacturing processes.

Andelyn Biosciences' Comprehensive Manufacturing Services

Andelyn Biosciences offers an extensive range of manufacturing services, including plasmid manufacturing, process development, and GMP manufacturing capacity for both adherent and suspension processes up to 2,000L. The company's services cater to both adherent and suspension-based viral vector and vaccine manufacturing, providing flexibility and scalability in production. Their rigorous process development guidelines, incorporating principles like Design of Experiments (DoE) and Quality by Design (QbD), ensure robust and reliable manufacturing outcomes.

Andelyn Biosciences' Support for Clinical and Preclinical Studies

Andelyn Biosciences is dedicated to supporting clients through all phases of development and commercialization. They manufacture research and toxicology grade viral vectors and plasmids that are crucial for preclinical studies. Additionally, they offer Phase I/IIa plasmid manufacturing services, ensuring that early-stage clinical trials have the high-quality materials necessary for successful outcomes. This extensive support illustrates the company's comprehensive approach to facilitating the development of groundbreaking therapies.

Andelyn Biosciences' Digital Model and Regulatory Support

A key aspect of Andelyn Biosciences' success is its integrated digital model and robust quality system, which streamline operations and ensure compliance with regulatory standards. The company provides full regulatory support, encompassing all necessary documentation and guidance to navigate the complex approval processes. Furthermore, Andelyn's supply chain vertical integration enhances efficiency and reliability, ensuring that materials are consistently available and meet stringent quality criteria.