Catalent, S.Biomedics Partner on Parkinson’s Cell Therapy

Catalent and S.Biomedics have entered into a strategic partnership to advance the development and manufacturing of TED-A9, an investigational allogeneic pluripotent stem cell-derived therapy being developed for the treatment of Parkinson’s disease.

TED-A9 consists of ventral midbrain–specific dopaminergic precursor cells derived from pluripotent stem cells. The therapy is designed to replace the dopamine-producing neurons that progressively degenerate in patients with Parkinson’s disease, a neurodegenerative disorder characterized by tremors, rigidity, bradykinesia and impaired motor control. By restoring dopaminergic signaling in the brain, the therapy aims to address the underlying pathology rather than merely alleviating symptoms.

The program builds on S.Biomedics’ proprietary targeted embryonic stem cell differentiation (TED) platform, which is designed to generate highly specific neuronal cell types for regenerative medicine applications. TED-A9 represents a central component of the company’s broader pipeline of stem cell-based therapies and reflects years of preclinical development.

Tony Kang, Chief Executive Officer of S.Biomedics, said the initiation of the company’s first U.S. clinical study—designed as a pivotal trial—marks a significant milestone. He emphasized that establishing a scalable, Good Manufacturing Practice (GMP)-ready infrastructure is critical to supporting late-stage development and positioning the therapy for potential commercialization. Kang added that partnering with Catalent will help create a strong manufacturing foundation capable of supporting global access if the therapy proves successful.

Under the agreement, Catalent will deploy its advanced cell therapy development and manufacturing capabilities to support TED-A9. The company brings expertise in analytical services, process development and GMP manufacturing, as well as experience working with induced pluripotent stem cells (iPSCs) and embryonic stem cells (ESCs). Catalent’s global network of facilities and integrated platforms are expected to help streamline the transition from early development through clinical supply and, ultimately, commercial launch.

David McErlane, Group President of Biologics at Catalent, noted that the company’s infrastructure is designed to help innovators progress confidently through pivotal trials toward commercial readiness. He said the collaboration aims to establish a robust and scalable production model that can accelerate patient access to promising regenerative therapies.

As interest in regenerative medicine continues to grow, partnerships between biotech innovators and specialized contract development and manufacturing organizations are increasingly critical. For S.Biomedics, the collaboration with Catalent represents a key step toward translating stem cell science into a potential new treatment option for patients living with Parkinson’s disease worldwide.