Cellares, an integrated development and manufacturing organization (IDMO) headquartered in South San Francisco, and Papillon Therapeutics, a clinical-stage biotechnology company based in San Diego, announced a collaboration to automate manufacturing of PPL-001, Papillon’s investigational gene-corrected hematopoietic stem and progenitor cell (HSPC) therapy for Friedreich’s ataxia, a rare disease that primarily affects children and adolescents.

Under the agreement, Cellares will adapt Papillon’s manufacturing process to its Cell Shuttle automated cell therapy manufacturing platform and support release testing using its Cell Q automated quality control system. According to the companies, the closed-system manufacturing process is intended to improve manufacturing consistency while reducing process variability for HSPC-based therapies.

PPL-001 is being developed to correct the GAA repeat expansion in the FXN gene, the genetic mutation responsible for more than 95% of Friedreich’s ataxia cases. The investigational therapy has received FDA Orphan Drug Designation and Rare Pediatric Disease Designation. Development of the program is also supported by grants from the California Institute for Regenerative Medicine (CIRM), the Friedreich’s Ataxia Research Alliance (FARA) and the National Institutes of Health (NIH).

The collaboration follows another recent manufacturing agreement for Cellares. Last week, the company partnered with Sonoma Biotherapeutics to automate production of its Phase 1 engineered regulatory T-cell (Treg) therapy using the Cellares automated quality control system.