COLUMBUS, Ohio, May 13, 2026
Andelyn Biosciences announced that it has received full certification under the Initiative for Certification of Manufacturing Capabilities (ICMC™) program from Dark Horse Consulting, a major milestone validating the company’s manufacturing quality systems, operational readiness, and commercial capabilities in the rapidly expanding cell and gene therapy sector. The certification recognizes Andelyn as a verified and compliant manufacturer capable of supporting advanced therapeutic manufacturing programs under globally aligned regulatory and commercial GMP standards.
The certification positions Andelyn Biosciences among a select group of advanced therapy Contract Development and Manufacturing Organizations (CDMOs) that have undergone rigorous third-party evaluation of manufacturing infrastructure, quality systems, production controls, and regulatory compliance processes. Industry experts continue to view independent certification programs as increasingly important as biotechnology companies seek reliable manufacturing partners capable of supporting complex gene therapy development from preclinical stages through commercial production.
According to Dark Horse Consulting, the ICMC program was developed to address a growing industry need for objective and standardized assessments of CDMO capabilities within the advanced therapeutics sector. The framework evaluates critical operational areas including quality management systems, GMP implementation, technology transfer, production controls, digital systems, laboratory operations, and commercial manufacturing readiness.
Certification Highlights Manufacturing Excellence
Andelyn Biosciences stated that the certification reflects years of investment in operational infrastructure, technical expertise, and advanced manufacturing systems designed specifically for gene and cell therapy programs. Company executives emphasized that confidence in manufacturing partners has become a critical factor for therapy developers navigating complex regulatory and commercialization pathways.
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The company currently supports a broad range of advanced therapy capabilities including viral vector manufacturing, plasmid manufacturing, process development, analytical development, quality control, technology transfer, and cGMP clinical and commercial manufacturing. These services are increasingly important as the number of gene therapy programs entering clinical development continues to accelerate globally.
Andelyn executives noted that the certification validates the company’s ability to support sponsors throughout the full therapeutic development lifecycle, from early-stage process development to commercial-scale production. The company believes the independent recognition may strengthen trust among biotechnology developers seeking experienced manufacturing partners for highly regulated gene therapy programs.
The ICMC assessment also reviewed Andelyn’s advanced digital manufacturing systems and operational infrastructure. The company’s proprietary DIGITAL CDMO® platform was highlighted as part of its integrated strategy for improving manufacturing efficiency, scalability, and data-driven production oversight in advanced biologics manufacturing.
Growing Demand for Gene Therapy Manufacturing
The cell and gene therapy industry continues to experience rapid growth as biotechnology companies advance next-generation therapies targeting rare diseases, oncology indications, and genetic disorders. However, manufacturing complexity remains one of the largest barriers facing therapeutic developers, particularly for viral vector production and commercial scalability.
Andelyn Biosciences currently operates development and manufacturing facilities in Columbus, Ohio, where the company has supported more than 500 clinical manufacturing batches and over 85 global clinical trials during the past two decades.
The company’s manufacturing infrastructure includes suspension-based production processes up to 2,000 liters, adherent manufacturing systems, integrated supply chain support, and comprehensive quality oversight programs designed to meet evolving global regulatory expectations for biologics and advanced therapies.
Bio-Pharma Manufacturing Sector Expands
As demand for cell and gene therapies grows worldwide, CDMOs with validated manufacturing systems and commercial readiness are becoming increasingly valuable across the biopharmaceutical industry. Analysts expect continued investment in viral vector manufacturing, plasmid production, and advanced therapy supply chains as more investigational therapies move toward regulatory approval and commercialization.
The ICMC certification further strengthens Andelyn Biosciences’ position in the competitive Bio-Pharma manufacturing landscape while reinforcing broader industry emphasis on quality assurance, GMP compliance, and scalable manufacturing capabilities for next-generation therapeutics.
Source: Andelyn Biosciences press release
