Leiden, Netherlands — NecstGen, the Netherlands Center for the Clinical Advancement of Stem Cell and Gene Therapies, is proud to announce the successful completion of a consultancy project in collaboration with Dr. Debby Gawlitta from the Department of Oral and Maxillofacial Surgery & Special Dental Care at UMC Utrecht. The project focused on providing a technical and cost analysis of manufacturing options for Dr. Gawlitta’s innovative mesenchymal stromal cell (MSC)-derived spheroid therapy for bone defects.
Dr. Gawlitta’s research has demonstrated promising preclinical results in endochondral bone regeneration using MSC-derived spheroids. To bridge the gap between research and clinical application, this consultancy project assessed the feasibility and scalability of Good Manufacturing Practice (GMP) production for the therapy, offering insights into technical requirements, cost considerations, testing strategy, and potential pathways to clinical implementation.
Paul Bilars, CEO of NecstGen, highlighted the significance of the project:
“This consultancy project underscores our commitment to supporting innovators like Dr. Gawlitta in overcoming the technical challenges of advancing groundbreaking therapies. By offering tailored advice on manufacturing strategies, we aim to accelerate the translation of promising research into impactful patient treatments.”
Dr. Gawlitta expressed her appreciation for the collaboration:
“The consultancy provided by NecstGen has supported shaping the next steps for our therapy. Their expertise has clarified the technical and cost-related aspects of GMP manufacturing, enabling us to make informed decisions as we move toward clinical translation. With this foundation, we are better positioned to bring our bone regeneration therapy closer to reality.”
This project was supported by a RegMed XB/Dutch Cardiovascular Alliance Thematic Tech Transfer Voucher, which enabled the partnership and facilitated the evaluation of manufacturing options for this promising therapy.
About NecstGen
NecstGen is a non-profit CDMO and center of excellence for Cell and Gene Therapy, located in a purpose-built GMP facility at the Leiden Bio Science Park, the largest bio-cluster in the Netherlands. NecstGen specialises in providing contract development, manufacturing, and consulting services to support academic and industrial therapy developers.