Deal to establish a dedicated, first-of-its-kind, U.S. final stage API manufacturing and supply platform for Vesalius’s Peptual-branded active pharmaceutical ingredients ("APIs").
The collaboration expands Celularity’s regenerative longevity platform by applying Celularity’s U.S.-based manufacturing infrastructure and technical capabilities to support the development of Vesalius's Peptual®-branded peptide APIs at its Florham Park, New Jersey facility. It builds on Celularity’s experience manufacturing complex biologics to current good manufacturing practice ("cGMP") standards, extending those capabilities into peptide API manufacturing while supporting its broader vision of advancing regenerative longevity.
Under the collaboration, Celularity will perform downstream purification, processing, analytical testing and manufacturing activities using supplier-provided bulk peptide material. The work is intended to establish peptide-specific manufacturing processes that satisfy cGMP requirements, supported by defined product specifications, documented sourcing and lot-level traceability. The collaboration is intended to position the parties to respond to potential regulatory developments affecting peptide compounding. If and when the U.S. Food and Drug Administration ("FDA"), following its consideration of recommendations from the Pharmacy Compounding Advisory Committee ("PCAC"), adds covered peptide substances and forms to its list of bulk drug substances that may be used in compounding under federal law, the parties intend to supply eligible Peptual-branded APIs to appropriately licensed U.S. compounding pharmacies. The collaboration will not involve manufacturing GLP-1 receptor agonists or other weight-loss peptides, as these products are excluded from Vesalius’s business model.