Dark Horse Consulting Group (“DHCG” or “the Group”), a leader in strategic and operational biotherapeutics consulting, and Porton Advanced, a premier contract development and manufacturing organization (CDMO) specializing in Advanced Therapy Medicinal Products (ATMPs), today announced the signing of a Memorandum of Understanding (MOU) to establish a strategic collaboration aimed at accelerating the development and clinical translation of cell and gene therapies globally.

This partnership unites DHCG's comprehensive regulatory, CMC, nonclinical, clinical, quality & compliance, supply chain, commercial launch, and business analytics consulting capabilities with Porton Advanced's end-to-end GMP manufacturing infrastructure, spanning lentiviral vectors, AAV, mRNA/LNP, plasmids, and engineered cell therapies including CAR-T, CAR-NK, and iPSC-derived products. Together, the two organizations will offer client companies a cost-effective and rapid pathway into clinical-stage manufacturing, with particular emphasis on enabling Investigator-Initiated Trials (IITs) in China.

For clients seeking to conduct Investigator-Initiated Trials in China, one of the most rapidly growing and strategically significant markets for advanced therapies, this collaboration addresses a persistent challenge: navigating the intersection of international regulatory strategy and local manufacturing. Porton Advanced holds 24 IND clearances across the NMPA and FDA and has successfully supported over 30 IITs to date. DHCG brings deep experience guiding sponsors through the complex regulatory and clinical design requirements that such programs demand.

By combining these capabilities under a formal collaborative framework, DHCG and Porton Advanced will enable sponsors and investigators to move their programs forward with greater speed, confidence, and efficiency, reducing friction at the manufacturing-regulatory interface that can result in delays in IIT initiation.

“This MOU with Porton Advanced represents a streamlined pathway for our client partners that are interested in undertaking an IIT in China,” said Anthony Davies, Ph.D., Founder and CEO of Dark Horse Consulting Group. “For programs targeting the Chinese market, particularly those pursuing IITs, having a trusted, proven manufacturing partner with NMPA-aligned quality systems will provide DHCG clients with decreased times to first-in-human, and rapid tech transfer and manufacture. We are committed to helping developers move therapies to patients faster, and this MOU is a direct expression of that commitment.”

“We are thrilled to enter into this agreement with Dark Horse Consulting Group, whose advisory capabilities spanning CMC, regulatory, nonclinical, and clinical are highly complementary to our manufacturing capabilities,” said Andrew Chen, CEO of Porton Advanced. “As demand for IIT-enabling services in China from overseas sponsors continues to grow, the combination of Porton Advanced’s end-to-end cell and gene therapy CDMO capabilities and proven track record, as well as DHCG’s strategic consulting depth creates a genuinely differentiated offering for developers at every stage.”