Biologics Manufacturing Resource

Overview of Services

The Biologics Manufacturing Resource (BMR) comprises over 2300 sq ft of laboratory suites, including ISO 7 cleanrooms, a QC laboratory, research and development, LN2 storage, inventory, and associated offices. Critical spaces maintain controlled access using an electronic card key system. Current Good Manufacturing Practices (cGMPs) are followed for all BMR products. A robust quality assurance program is in place that includes environmental monitoring, continuous equipment and facility monitoring with remote alarms, appropriate gowning practices, and documented facility and equipment cleaning and maintenance.  

The BMR maintains these facilities, equipment, and personnel for manufacturing a wide range of cellular therapeutic products for clinical trials, such as NK cells, CAR T cells, and CARNK Cells. Biologics Manufacturing also manufactures irradiated CSTX002 feeder cells for ex vivo expansion of NK cells, available at clinical grade or research grade for process development or preclinical validation. Along with all the cell products manufactured by the BMR, Biologics Manufacturing completes the processing of a tissue engineered vascular graft (TEVG) in support of an ongoing clinical trial. Additional products can be offered through process development or technology transfer as needed. 

Lawrence Gazda, Director
614-355-5692
lawrence.gazda@nationwidechildrens.org

Prithy Martis, Supervisor
614-722-1441
prithy.martis@nationwidechildrens.org

Shane Wellman, Business Manager
614-355-3598
Shane.Wellman@nationwidechildrens.org

Location and hours of operation

Links and Resources

Contacts