CCHMC Translational Core Laboratory
directed by Punam Malik, M.D
(513) 636-8588
a member since 2/16/2008

Contact Info

For information contact
Diana Nordling.

(513) 803-1063
Cincinnati Children's Hospital Medical Center
3333 Burnet Avenue, MLC 7013
Cincinnati, OH 45229

(513) 636-3468
(513) 635-1446

Services Provided

This facility provides research grade material and offers production support to both Academics and Companies.

Misc Services

  • In-vitro and small animals in-vivo toxicology
  • Insertion site analysis
  • clinical trial monitoring assays
  • Material formulation and sterile packaging.

Biologics Produced

  • working cell banks
  • Pluripotent Stem Cells
  • Human iPS cells
  • Hematopoietic Progenitor Cells
  • Hematopoietic Cell Isolations

Vector Support

  • Retrovirus
  • Lentivirus
  • Adenovirus
  • AAV

Notable Affiliations

CAP, FDA-Registered Facility, DMF/BBMF Filed with FDA

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-grade viral 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, insertion site analysis 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 10,000 square feet facility includes 9 ISO Class 7 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.