Andelyn Biosciences strengthens CDMO credentials with full ICMC certification

Andelyn Biosciences, a leading cell and gene therapy Contract Development and Manufacturing Organisation (CDMO), has announced it has received full certification under the Initiative for Certification of Manufacturing Capabilities (ICMC) program from Dark Horse Consulting, recognising the company’s capability to support advanced therapies manufacturing with its quality and production systems.
 
The Dark Horse Consulting ICMC program was established to address an industry-wide gap in independent evaluation of CDMO capabilities to support advanced therapeutics manufacturing. The program’s evaluation criteria are based on global regulatory standards for commercial manufacturing. Without such assessment, selecting a CDMO for therapeutic developers can become a risky proposition and compromise the success of a therapeutics program. In the ICMC program, CDMO credibility is established through an extensive due diligence effort on manufacturing capabilities, defined by systems, competencies, and criteria aligned with industry and regulatory standards, including biological drug product inspection guidance and commercial GMP requirements. The certification framework aims to provide a structured, objective, and globally consistent evaluation of CDMO systems.
 
The certification received by Andelyn underscores their long-standing commitment to quality, operational readiness, and client service as the company supports innovators in advancing gene therapies from development through clinical and commercial manufacturing.
 
“Andelyn’s receipt of the ICMC certification reflects the strength of the teams, culture, and infrastructure we have built to support complex gene therapy programs,” said Wade Macedone, Chief Executive Officer of Andelyn Biosciences. “For sponsors, confidence in a manufacturing partner is critical. This certification reinforces Andelyn’s commitment to quality, transparency, and technical excellence as we help clients advance transformative therapies toward patients.”
 
Through the ICMC, CDMO credibility is established through rigorous assessment across manufacturing site systems, including quality, digital systems, facilities and equipment, materials, production, laboratory controls, and commercial readiness. The criteria address critical areas, including technology transfer, GMP implementation, quality systems, facility and equipment readiness, materials management, production processes, and laboratory controls.
 
This achievement builds on Andelyn’s ongoing investments in advanced therapy program capabilities, including viral vector manufacturing, plasmid manufacturing, process development, analytical development, quality control, technology transfer, and the company’s DIGITAL CDMO® platform. Together, these capabilities support Andelyn’s mission to accelerate the development and manufacturing of innovative therapies to bring more treatments to more patients.
 
“Gene therapy sponsors need manufacturing partners with real experience, dependable systems, responsive service, and scalable capabilities,” said Matt Niloff, Chief Commercial Officer of Andelyn Biosciences. “With the ICMC certification validating core capabilities required for gene therapy manufacturing, our clients can have the confidence they are choosing to work with the right partner, one that is fully capable of advancing their program to the clinic and to commercial manufacturing upon approval.”
 
ICMC Certification is a fully objective program and is not intended to act as an endorsement of any specific CDMO or to replace a formal product- or customer-specific audit.

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Andelyn Biosciences 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...

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