Cell and Gene Therapy CDMO Andelyn Biosciences Celebrates Over 20 Years of Leadership and Innovation with Opening of New 180,000 Square Foot Manufacturing Headquarters

22 June 2023 -- Ohio, US -- Andelyn Biosciences, a pioneer in the development and manufacturing of cell and gene therapies (CGTs), today formally inaugurates its new manufacturing headquarters, the Andelyn Corporate Center (ACC), located in the Innovation District in Columbus, Ohio. The newly constructed state-of-the-art and regulatory-compliant facility complements Andelyn’s two existing facilities in Columbus.

Wade Macedone, CEO of Andelyn Biosciences, commented, “The opening of the new ACC is a fitting tribute to our more than 20 years of leadership and innovation in the development and manufacture of viral vectors for gene therapy. The new facility includes 16 cGMP modular manufacturing suites with upstream, downstream, solution prep and filling capabilities, along with quality control labs and warehouse and corporate headquarters space. This expansion significantly enhances the comprehensive Concept-to-Commercialisation capabilities we provide to our biotechnology and pharmaceutical clients.”

Macedone continued, “We are proud of our record of success in this demanding field, with over 2,000 viral vector production runs and more than 450 cGMP batches delivered in support of more than 75 global gene therapy clinical trials. Our talented workforce of over 200 people never lose sight of the ultimate goal – to help eradicate the many debilitating and deadly genetic disorders that were formerly untreatable. We view expansion with the ACC as positioning Andelyn for continued leadership and growth that, in turn, will help advance the fields of CGT and help bring curative treatments to more patients.”

From its origins operating development and cGMP manufacturing supporting pioneering gene therapy efforts at Nationwide Children’s Hospital, Andelyn has expanded to three buildings with more than 250,000 combined square feet of space, including the ACC, the Andelyn Development Center (ADC) for preclinical non-cGMP activities, and the Andelyn Plasmid Center (APC) for research and cGMP plasmid production. Andelyn has broad expertise in all aspects of viral vector development and manufacturing, from preclinical starting materials through development, manufacturing and fill and finish for clinical trial and commercial scale production. Supporting services include analytical development and quality control, quality assurance and regulatory support.

Andelyn’s decades of experience have led to the development of a configurable adeno-associated virus (AAV) platform, which provides performance predictability and drives faster development, optimisation and efficiency in the manufacturing process. Reflecting the company’s vast experience in analytical development and viral vector programme execution, products manufactured at Andelyn are of consistently high quality, characterised by safety, purity, potency and yield – attributes that are measured extensively throughout the production, purification, release and stability process. The company also supports the development and manufacturing of other viral vector processes and cell-based gene therapies.

About Andelyn Biosciences
Andelyn Biosciences is a full-service CGT CDMO focused on the development, characterisation and production of viral vectors for gene therapy. With more than 20 years of experience, Andelyn’s deep scientific expertise has resulted in the production of cGMP material for more than 450 clinical batches and 75 global clinical trials. Andelyn supports customers developing curative CGTs from concept through plasmid development and manufacturing, process development and cGMP clinical and commercial manufacturing. Its versatile capabilities include cGMP manufacturing capacity for both adherent and suspension processes up to a 2,000-litre capacity. An advanced digital model, quality system, full regulatory support and supply chain vertical integration help Andelyn accelerate the development and manufacturing of its clients’ innovative CGTs. For more information, visit andelynbio.com.