RoslinCT and BOOST Pharma Announce Strategic Manufacturing Agreement to Advance Cell Therapy for Infants with Osteogenesis Imperfecta

RoslinCT, a global contract development and manufacturing organization (CDMO) specializing in advanced cell therapies, and BOOST Pharma, a clinical-stage biotechnology company developing first-in-class cell therapies for rare paediatric skeletal diseases, today announced a strategic manufacturing partnership to support the development of BOOST Pharma’s cell therapy, BT-101, for the treatment of infants with Osteogenesis Imperfecta (OI), also known as brittle bone disease.

Under the service agreement, BOOST Pharma has transferred its manufacturing process to RoslinCT’s state-of-the-art facilities in Edinburgh, Scotland. The partnership will progress toward GMP manufacturing of starting materials and clinical drug product, supporting Phase III clinical development of BT-101. The therapy is an allogeneic mesenchymal stem cell (MSC) product designed to address the underlying cause of OI at the earliest stages of life.

BOOST Pharma was founded on pioneering science originating from Karolinska Institutet, a world leader in cell therapy research. Its lead program, BT-101, is a novel MSC-based therapy with high bone-forming capability. Preclinical and clinical studies have demonstrated promising results, including improved bone formation, reduced fracture rates, and sustained growth in children with severe forms of OI, with no observed immune response to donor cells.

OI is a rare, inherited genetic disorder characterized by extremely fragile bones, skeletal deformities, pain, and reduced quality of life. There are currently no EMA or FDA approved disease-modifying treatments for OI, and existing interventions are largely palliative. By enabling early intervention, including prenatal or early postnatal treatment, BT-101 has the potential to significantly alter disease progression and long-term outcomes for affected children.

“This partnership with RoslinCT represents a critical milestone as we prepare for late-stage clinical development,” said Lilian Walther Jallow, Co-founder and Chief Development Officer of BOOST Pharma. “We know all too well the challenges associated with the CMC part for cell therapies, so for BOOST, it was of great importance to early prioritize finding a partner that we could work with all the way through to a commercial product. 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.”

From RoslinCT’s perspective, the agreement reflects a shared, long-term commitment to patient-focused innovation in rare paediatric diseases.

“At the heart of this partnership are infants and families facing a devastating diagnosis with no curative treatment options,” said Peter Coleman, Chief Executive Officer of RoslinCT. “Supporting the manufacture of a therapy that has the potential to reduce fractures, ease pain, and fundamentally change the life trajectory of children with Osteogenesis Imperfecta is deeply meaningful for our team. We see this as a long-term manufacturing relationship, supporting BOOST Pharma not only through Phase III, but also through commercial manufacturing as this therapy moves closer to becoming a reality for patients.”

RoslinCT will provide end-to-end CDMO support, leveraging its expertise in allogeneic cell therapies, process transfer, and GMP manufacturing to ensure robust, scalable production aligned with BOOST Pharma’s clinical and future commercial goals.

About BOOST Pharma ApS

BOOST Pharma is a clinical-stage biopharmaceutical company focused on the development of novel cell therapy treatments. The company is currently developing a first-in-class therapy to treat Osteogenesis Imperfecta, a severe, inherited rare genetic disease leading to significant physical disability. BOOST Pharma is supported by Industrifonden, Sound Bioventures and Karolinska Development, Sweden.

About Osteogenesis Imperfecta

Osteogenesis Imperfecta (OI), also known as Brittle Bone Disease, is a rare and devastating genetic disease, with currently no approved therapies. OI is characterized by fragile bones and reduced bone mass resulting in bones that break easily, loose joints, and weakened teeth. In severe cases, those with OI may experience hundreds of fractures in a lifetime. In addition, people with OI often suffer muscle weakness, early hearing loss, fatigue, curved bones, scoliosis, respiratory problems, and short stature, leading to significant effects on overall health and quality of life. Current treatment of OI is only supportive, focusing on minimizing fractures and maximizing mobility, but to date there are no FDA or EU approved treatments. OI is estimated to affect 1 in 15,000 people globally.

About RoslinCT

RoslinCT is a leading global CDMO focused on advanced cell therapies. With 22 purpose-built cGMP cell therapy suites across sites in Edinburgh, Scotland, and Hopkinton, Massachusetts, RoslinCT provides process and analytical development, clinical and commercial manufacturing for autologous and allogeneic cell therapies, as well as iPSC cell line development, gene editing, and differentiation services.

Founded in 2005 and built on the scientific heritage of the Roslin Institute - home of the groundbreaking cloning of Dolly the Sheep - RoslinCT has played a pivotal role in advancing innovative cell-based medicines from early development through commercialization, with manufacture of commercial products at both sites.

RoslinCT is a GHO Capital portfolio company.

Learn more at: www.roslinct.com

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