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Rentschler Biotechnologie will manufacture GMP material for advanced clinical studies and market supply of Apeiron's lead program, APN311.
Apeiron Biologics AG, and Rentschler Biotechnologie GmbH announced a partnership agreement to manufacture GMP material for various advanced clinical studies and later on for market supply of Apeiron’s lead program, APN311.
APN311 is a chimeric antibody that targets the GD2 antigen, which is abundantly expressed on neuroblastoma cells. The program is currently being evaluated in several clinical trials in patients with high-risk neuroblastoma, the most common extracranial solid tumor seen in children.
Decisive factors in Apeiron’s partnering selection were Rentschler’s ability to keep the very challenging project timelines and their technical and regulatory expertise in phase III and market projects, the company reports. Apeiron receives access to experienced teams, appropriate mammalian cell culture capacity for clinical phase I to III and commercial production, fill and finish services as well as a scientific-driven and responsive project management. The partnership agreement includes the transfer of the manufacturing process to Rentschler, GMP manufacturing, and process validation in preparation of the MAA/BLA submission as well as future market supply.
Source: B3C Newswire