- RoslinCT and BOOST Pharma have entered a strategic manufacturing partnership to support GMP production of the cell therapy BT-101 for infants with Osteogenesis Imperfecta.
- The agreement includes process transfer to RoslinCT’s Edinburgh facility and will support Phase III clinical development and future commercial manufacturing.
RoslinCT and BOOST Pharma have announced a strategic manufacturing partnership to support the development of BOOST Pharma’s cell therapy candidate, BT-101, for the treatment of infants with Osteogenesis Imperfecta (OI). The collaboration focuses on enabling late-stage clinical development of the therapy through GMP manufacturing.
Under the service agreement, BOOST Pharma has transferred its manufacturing process to RoslinCT’s facilities in Edinburgh, Scotland. The partnership will progress towards GMP manufacturing of starting materials and clinical drug product, supporting Phase III clinical development. BT-101 is an allogeneic mesenchymal stem cell therapy designed to address the underlying cause of OI at the earliest stages of life.
BOOST Pharma stated that its lead programme originated from research at Karolinska Institutet and has shown promising results in preclinical and clinical studies, including improved bone formation and reduced fracture rates in children with severe OI. The company noted that there are currently no EMA- or FDA-approved disease-modifying treatments for the condition, with existing care largely focused on symptom management.
“This partnership with RoslinCT represents a critical milestone as we prepare for late-stage clinical development. RoslinCT brings deep technical expertise and GMP manufacturing capability that will be essential as we advance BT-101 toward Phase III and, ultimately, toward patients who urgently need new treatment options.”
Lilian Walther Jallow, Co-founder and Chief Development Officer of BOOST Pharma
RoslinCT said it will provide end-to-end CDMO and contract manufacturing support, including process transfer and GMP production, with the intention of supporting BOOST Pharma through Phase III development and into potential commercial manufacturing.
