-Andelyn Extends its Capabilities to Meet Growing Demand for Cell and Gene Therapy Development and Manufacturing with Addition of Third Columbus, Ohio Facility-
–Andelyn’s Concept–to–Commercialization Capabilities Range from Starting Materials through Development, Manufacturing and Fill and Finish, Along with Analytical Development, Quality Control, Quality Assurance and Regulatory Support-
-With More than 20 Years Experience, 200+ Employees, and 2,000+ AAV Production Runs, Andelyn Offers Extensive Experience and Expertise in All Aspects of Gene Therapy Viral Vector Production-
COLUMBUS, Ohio–(BUSINESS WIRE)–June 22, 2023–
Andelyn Biosciences, a pioneer in the development and manufacturing of cell and gene therapies, 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. With 180,000 square feet of office, laboratory, and manufacturing space, the ACC more than triples Andelyn’s footprint, ensuring the company will have the space and capabilities to meet the growing demand for its cell and gene therapy services.
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Wade Macedone, Chief Executive Officer of Andelyn Biosciences, commented, “The opening of the new Andelyn Corporate Center 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-Commercialization 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 cell and gene therapy and help bring curative treatments to more patients.”
Click here to see a video highlighting the capabilities available at the new Andelyn Corporate Center facility.
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, optimization, and efficiency in the manufacturing process. Reflecting the company’s vast experience in analytical development and viral vector program execution, products manufactured at Andelyn are of consistently high quality, characterized 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, Inc.
Andelyn Biosciences is a full-service cell and gene therapy CDMO focused on the development, characterization 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 cell and gene therapies 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-liter 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 cell and gene therapies. For more information, visit andelynbio.com.
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