AGC Biologics Joins OXTL’s Clinical Development Network as a Manufacturing Partner

AGC Biologics, a global biopharmaceutical Contract Development and Manufacturing Organization (CDMO), has joined Orphan Therapeutics Accelerator’s (OTXL’s) Clinical Development Network (Orphan ClinDevNet) as a manufacturing partner.

The strategic alliance expands existing collaboration between the two organizations and strengthens OTXL’s ability to advance cell and gene therapies for ultra-rare conditions with coordinated, end-to-end manufacturing capabilities.

OTXL’s Orphan ClinDevNet brings together specialized partners committed to overcoming the most persistent barriers to development and commercialization of ultra-rare disease treatments, from the cost and pace of late-stage clinical trials to the difficulty of maintaining continuity and scaling manufacturing once a therapy is approved. OTXL and its network partners work together to help lower upfront development costs, de-risk the path to market, and enable more therapies to reach patients.

“Despite major advances in cell and gene therapy, the commercial sustainability of treatments for ultra-rare diseases remains a critical hurdle, preventing many proven therapies from reaching patients,” said Luca Alberici, Vice President of the Cell and Gene Technologies Division at AGC Biologics. “At AGC Biologics, we have built the specific expertise and infrastructure to sustainably manufacture these products, demonstrated by our success with numerous commercial CD34+ HSC-based therapies. Our alliance with OTXL expands our network of partners dedicated to bringing these life-changing treatments to patients by creating a new, viable model for the rare disease ecosystem.”

AGC Biologics’ cell and gene therapy platform, anchored in autologous CD34+ hematopoietic stem and progenitor cells transduced with lentiviral vectors, is directly applicable to the kinds of programs OTXL is onboarding. The collaboration also builds on AGC Biologics’ prior work supporting therapies that had been considered commercially nonviable under traditional industry practices due to small patient populations and high per-patient manufacturing costs.

“AGC Biologics’ global footprint extends our ability to connect with patients and treatment centers across more geographies. This is a major benefit when serving populations as small and dispersed as those affected by ultra-rare diseases, as ultimately, we want to get therapies to the patients who need them, wherever they may be,” added Craig Martin, CEO and Co-founder, Orphan Therapeutics Accelerator.