Clean Cells, a biopharma quality control services provider specialising in biologics GMP testing, has acquired Stem Genomics, a developer of next-generation quality control technologies for stem cell therapy.
The deal, announced yesterday, gives Clean Cells access to Stem Genomics' core asset, the iCS-digital Pluripotent Stem Cells (PSC) platform, a digital PCR-based assay capable of detecting more than 90% of recurrent chromosomal abnormalities in stem cell cultures.
The acquisition covers Stem Genomics in its entirety, including its French operating entity and the US corporation, Stem Genomics Inc., which is based in Durham, North Carolina.
Alongside the iCS-digital platform, Clean Cells gains the Stem-Seq next-generation sequencing panel for genomic stability analysis and the Pluri-digital assay for monitoring pluripotency and differentiation.
All 17 Stem Genomics employees will transfer across both sites.
The move builds on Clean Cells' earlier US expansion.
The company, part of the ARCHIMED-backed Clean Biologics group, acquired Karyologic, a Durham-based cytogenetic testing specialist, in a deal that closed at the end of March last year.
Because Stem Genomics' US laboratory sits in the same Research Triangle Park building as KaryoLogic, Clean Cells can now combine genomic stability testing and karyotyping under one roof, with Stem Genomics CEO Nicolas Chapal taking charge of the combined Stem Cell Business Unit.
For pharmaceutical manufacturers and biotech developers, the acquisition is designed to close a gap in the cell therapy testing chain, extending Clean Cells' service offering from early-stage genomic integrity checks through cell banking and viral safety testing to GMP lot release.
Laurent Claisse, CEO of Clean Cells, described the deal as completing the company's cell therapy quality control platform.
Cell and gene therapy developers need reliable partners. With this deal, we are expanding our ability to support research teams from their early genomic stability testing through to cell banking and viral safety testing to GMP lot release.
The transaction lands as regulators tighten expectations around genomic integrity documentation ahead of clinical use, particularly for induced pluripotent stem cell (iPSC)-derived therapies targeting oncology, neurological disease and rare conditions.
Clean Cells cites analyst projections putting the stem cell assay market at $4.6bn in 2025, rising to $10.27bn by 2035.
Financial terms of the acquisition were not disclosed. Ludovic Alonzi, Partner at ARCHIMED, said the deal positions the Clean Biologics group to cover the full quality control range for what he called the fastest-growing segment of the biopharmaceutical market.
For CDMOs and biotech sponsors managing iPSC and other advanced cell therapy programmes, the combined Clean Cells-Stem Genomics-KaryoLogic offering now provides a single-source route from genomic stability testing through to regulatory-ready lot release data, in both Europe and the US.
