About this facility

The Translational Core Laboratories at Cincinnati Children's Hospital Medical Center is designed to support principle investigators in preparation and conduct of early phase clinical trials. We offer the following services:

•          GMP viral vector production for clinical trials

•          Sterile formulation and packaging of viral vectors

•          GLP grade viral vectors for pre-clinical studies

•          Research vectors

•          GTP Hematopoietic cell manipulations including CD34+ enrichment and transduction

•          CLIA/CAP sample processing and assays for trial monitoring

•          CLIA/CAP hematopoietic stem and progenitor assays, and insertion site and other  molecular assays not available in routine laboratories

•          Controlled, SOP driven hematopoietic stem and progenitor assays

•          Controlled, SOP driven in-vitro and small animal in-vivo toxicology studies

•          Hematopoietic stem cells for IRB approved research

•          iPSC characterization

•          Process development for proposed manufacturing scale up and suitability

•          Assay development in support of gene therapy clinical trials

The approximately 12,000 square feet facility includes 9 cleanroom suites for more-than minimally manipulated human cell, viral vector manufacturing, vector formulation and fill, and additional 4 cleanrooms available as expansion space.  This space also includes development and support laboratories, and CLIA laboratories including a PCR suite.

Cleanrooms are validated to comply with ISO/GMP for early phase manufacture of products for use in US and Europe. Our highly trained personnel are proficient in manufacturing and testing according to applicable standards and have successfully adapted research level processes to early phase GMP compliance.