Dark Horse Consulting Launches Initiative for Certification of Manufacturing Capabilities

Initiative for Certification of Manufacturing Capabilities (“ICMC™”), a groundbreaking offering designed to close a critical gap in the CGT CDMO market.

ICMC was conceptualized as a way to meet the growing demand for transparency and consistency in the rapidly expanding CGT CDMO landscape. Currently, new service providers are entering a market where their claims of providing compliant and scalable manufacturing services are not proactively verified by the relevant regulatory bodies. As such, the CDMO market is experiencing fragmentation and the perception of a diminished outsourcing value.

With an industry-leading track record in supporting both CGT therapeutic developers and manufacturing organizations, DHC is uniquely positioned to deliver credible and unbiased evaluations in order to help drug developers make informed decisions in selecting their manufacturing partner. DHC maintains a global database of CGT CDMOs and in the past 4 years has performed more than 50 CGT CDMO selection projects, more than 40 audits, and over 60 remediation projects.

The ICMC program offers the opportunity for CDMOs to opt-in to independent, third-party evaluations across nine capability systems following published criteria, ensuring a fair, objective, and comprehensive certification into the Certified Member Directory. This Directory is publicly available, providing developers with a trusted resource for initiating the selection of credible manufacturing partners.

“With ICMC, we are setting a new benchmark for transparency and trust in the CDMO marketplace,” said Anthony Davies, DHC Founder and CEO. “Sponsors often struggle to find credible, unbiased information when choosing a CDMO. ICMC is designed to help by providing a list of vendors with verified capabilities as a starting point for sponsors' CDMO selection process.”

Key benefits of the ICMC program include:

• Credibility: ICMC Certification builds trust between therapeutic developers and prospective CDMO partners
• Differentiation: ICMC Certification highlights the extent of capabilities that exist within the member CDMOs
• Visibility: The ICMC Certified Member Directory enables identification of credible manufacturing partners
  

Several early adopter partners—including ElevateBio, AGC Biologics, and Andelyn Biosciences—have already joined the program and the certification process has commenced. Discussions are ongoing with a number of additional prospective members.

About Dark Horse Consulting Group

Dark Horse Consulting Group, a global company with offices in the U.S., U.K., and Singapore, was founded in 2014 with the purpose of accelerating cell and gene therapies through unmatched consulting expertise. DHC's collective knowledge spans product and process development, analytical development, device development, facilities, manufacturing & compliance, quality assurance, project & program management, regulatory affairs, nonclinical development, clinical regulatory, quantitative modeling, market expertise, and diligence & business strategy. DHC offers an unmatched understanding of the challenges faced by cell and gene therapy developers and applies best practices from this and other industries to address a diverse range of client needs.

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