Dark Horse Consulting has announced a new third-party evaluation program designed to help therapeutic developers navigate cell and gene therapy CDMO choices.
ICMC (Initiative for Certification of Manufacturing Capabilities) was conceptualized as a way to meet the growing demand for transparency and consistency in the rapidly expanding CGT CDMO landscape.
ICMC offers CDMOs the opportunity 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. The certifications focus on the quality and operational capabilities required to manufacture various CGT therapeutic drug products in a compliant and scalable manner.
The free public directory will allow therapeutic developers to more robustly evaluate CDMO partners, while offering CDMOs a way to build credibility and differentiation in the marketplace.
The initiative was unveiled this past fall and now has three early adopter partners — ElevateBio, AGC Biologics and Andelyn Biosciences — with discussions ongoing with additional companies.
In October, Dark Horse made moves to extend its consulting reach beyond CGTs, acquiring Illinois-based BioTechLogic. The combined organization offers strategic advisory, operations, and technical consulting across the biopharma industry, creating a "powerhouse" in the biopharma consulting space, while retaining a critical focus on advanced therapies.
Subscribe to our e-Newsletters
Stay up to date with news, articles and insights relevant to cell and gene therapy development and manufacturing. Plus, get special offers from Cell & Gene Therapy Review delivered right to your inbox!
Sign up now!