RoslinCT and BOOST Pharma Forge Strategic Partnership to Advance Groundbreaking Cell Therapy for Infants with Osteogenesis Imperfecta
In a major step forward for pediatric rare disease therapy, RoslinCT, a globally recognized contract development and manufacturing organization (CDMO) specializing in advanced cell and gene therapies, has entered into a strategic manufacturing partnership with BOOST Pharma, a clinical-stage biotechnology company dedicated to developing first-in-class cell therapies for rare pediatric skeletal disorders. This collaboration will focus on the development and production of BOOST Pharma’s lead therapy, BT-101, a novel cell-based treatment designed for infants suffering from Osteogenesis Imperfecta (OI), a debilitating genetic disorder commonly referred to as brittle bone disease.
A Milestone for Clinical Development
“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. “Navigating the complex Chemistry, Manufacturing, and Controls (CMC) requirements for cell therapies is a significant challenge. From the outset, it was essential for BOOST to partner with an organization capable of supporting us through both clinical and commercial stages. RoslinCT’s technical expertise and GMP manufacturing capabilities make them the ideal partner as we move BT-101 closer to patients who urgently need innovative treatment options.”
Seamless Technology Transfer and GMP Manufacturing
Under the terms of the agreement, BOOST Pharma has transferred its proprietary manufacturing process to RoslinCT’s state-of-the-art facilities in Edinburgh, Scotland. The partnership will enable GMP-compliant production of starting materials and clinical drug products, supporting the Phase III clinical development of BT-101. As an allogeneic mesenchymal stem cell (MSC) therapy, BT-101 targets the root cause of OI, aiming to intervene at the earliest stages of life—including prenatal or early postnatal treatment.
BOOST Pharma’s BT-101 is grounded in pioneering science originating from Karolinska Institutet, a world leader in cell therapy research. Preclinical and early clinical studies of BT-101 have shown promising results, including enhanced bone formation, reduced fracture rates, and sustained growth in children with severe forms of OI. Importantly, these studies reported no immune response to donor cells, highlighting the therapy’s potential safety and efficacy profile.
Osteogenesis Imperfecta: A Rare Disease in Need of Innovation
Osteogenesis Imperfecta is a rare, inherited genetic disorder marked by extremely fragile bones, skeletal deformities, chronic pain, and reduced quality of life. Currently, no disease-modifying treatments have been approved by the European Medicines Agency (EMA) or the U.S. Food and Drug Administration (FDA). Existing interventions are largely palliative, focusing on symptom management rather than addressing the underlying genetic cause. By enabling early intervention, BT-101 has the potential to dramatically alter disease progression and improve long-term outcomes for affected children, offering hope to families facing a devastating diagnosis.
A Long-Term, Patient-Focused Collaboration
From RoslinCT’s perspective, the partnership represents more than a business agreement—it reflects a shared commitment to patient-centric innovation in rare pediatric diseases.
“At the heart of this partnership are infants and families confronting a condition with no curative treatment options,” said Peter Coleman, Chief Executive Officer of RoslinCT. “Supporting the manufacture of BT-101, a therapy with the potential to reduce fractures, ease pain, and fundamentally change the life trajectory of children with OI, is deeply meaningful for our team. We view this as a long-term relationship, encompassing not only Phase III clinical development but also the eventual commercial-scale manufacturing of this transformative therapy.”
RoslinCT will provide end-to-end CDMO support, leveraging its deep expertise in allogeneic cell therapies, process transfer, and GMP manufacturing. The collaboration ensures robust, scalable production aligned with BOOST Pharma’s clinical and commercial goals, positioning BT-101 to reach the patients who need it most.
Looking Ahead
As BT-101 progresses through late-stage clinical development, this partnership underscores the critical role of specialized manufacturing expertise in advancing novel cell therapies for rare pediatric conditions. Together, BOOST Pharma and RoslinCT are poised to transform the treatment landscape for Osteogenesis Imperfecta, offering hope for a future where infants born with brittle bones can lead healthier, more active lives.
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.
