Andelyn Biosciences Receives Dark Horse Consulting Certification of Gene Therapy Manufacturing Systems and Capabilities within its Initiative for Certification of Manufacturing Capabilities (ICMC™) Program
COLUMBUS, Ohio, May 13, 2026 — Andelyn Biosciences, a leading cell and gene therapy Contract Development and Manufacturing Organization (CDMO), today announced it has received full certification under the Initiative for Certification of Manufacturing Capabilities (ICMC) program from Dark Horse Consulting, recognizing 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, a CDMO's 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, a CDMO’s 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.
About 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 20 years of experience, Andelyn’s deep scientific expertise has resulted in the production of cGMP material for more than 500 clinical batches and 85 global clinical trials. Operating out of its development and manufacturing facilities in Columbus, Ohio, Andelyn supports its clients in developing cell and gene therapies from concept through plasmid engineering and manufacturing, process and analytical development, and cGMP clinical and commercial manufacturing.
Andelyn can accelerate programs and deliver high-quality products by developing and manufacturing processes on its configurable, data-driven Curator® Cell and Gene Therapy Platforms, or by tech transfer within an established client program. Capabilities include cGMP manufacturing for suspension processes up to 2,000 liters and adherent processes. A rigorous quality system, regulatory support, and supply chain vertical integration further advantage clients in bringing their critical therapies to market.
For more information, please visit andelynbio.com and follow Andelyn Biosciences on LinkedIn.
For Andelyn Biosciences media inquiries, please contact: media@andelynbiosciences.com.
About Dark Horse Consulting Group
Dark Horse Consulting Group, a worldwide consulting organization with offices in North America, Europe, and APAC, was founded in 2014 with the purpose of accelerating development and delivery of cell and gene therapies through unmatched expertise. Since then, The Group’s focus has expanded dramatically, with consulting team subject matter expertise now encompassing strategy, operations, Quality, regulatory affairs, manufacturing, modeling, supply chain, commercial launch, and business optimization across the biopharma landscape. DHCG’s white-glove client service is grounded in rigorous scientific and technical expertise to support clients from early discovery through commercial launch. The Group comprises three business units: DHC, BioTechLogic, and Converge Consulting, with Bruder Consulting & Venture Group forming a specialized Regenerative Medicine department of DHC as of early 2026 and CJP joining the group as a Dark Horse Consulting company, also in early 2026.