Current Cell and Gene Therapy (CGT) CDMO landscape is rapidly expanding with new service providers continuing to enter the market. Contract Development and Manufacturing Organization (CDMO) claims about ability to provide compliant and scalable manufacturing services are typically not proactively verified by the relevant regulatory bodies, thus therapeutic developers are often challenged with evaluating credibility of the prospective CDMO partners. As such, the CDMO market is experiencing fragmentation and perception of diminished value proposition of outsourcing.
Certification of CDMO capability claims by a credible independent party allows therapeutic developers to more robustly evaluate CDMO partners. Additionally, it allows CDMOs to build credibility and differentiation in the marketplace and introduces a level of standardization that is currently lacking.
With an industry-leading track record of cross-functional experience and expertise in supporting both CGT therapeutic developers and manufacturing organizations, Dark Horse Consulting Group (DHC) is uniquely positioned to act as the credible, expert, and unbiased party to perform such evaluations, as evidenced by the success and recognition of our global CDMO database and CDMO selection service offerings.
ICMC Certification builds trust between therapeutic developers and prospective CDMO partners
ICMC Certification highlights the extent of capabilities that exist within the member CDMOs
ICMC Certified Member Directory enables identification of credible manufacturing partners
ICMC Certification is a paid “opt-in” program, intended to verify capability and compliance claims of participating CDMOs by a credible, expert, and unbiased independent party. The scope of the certifications is focused on Quality and operational capabilities required to manufacture the various types of CGT therapeutic products in a compliant and scalable manner.
ICMC Certification is not intended to verify the level of scientific and technical subject matter expertise of member CDMOs, nor their ability to meet the requirements of their customers, as those are highly variable and largely product and business relationship dependent.
As such, ICMC Certification should not be viewed as an endorsement of any particular CDMO, nor as a surrogate for a formal product/customer-specific audit of a CDMO.
