Jan Nolta Lab 2010

We are opening february 2010, thanks to a generous major Facilities renovation grant from the California Institute for Regenerative Medicine (CIRM)!!

Please contact UCD GMP Facility Director Gerhard Bauer for rates and availability:

gerhard.bauer@ucdmc.ucdavis.edu

916-703-9302 

UC Davis Good Manufacturing Practice Facility

The newly constructed UC Davis Good Manufacturing Practice (GMP) facility in the IRC is the largest academic GMP facility in

It has some very unique features, such as a GMP grade FACS sorter, the ability of switchable room pressurization for gene therapy vector manufacturing, and also a hot cell for clinical grade PET reagent manufacturing (through an equipment grant obtained by Julie Sutcliffe). It features one way product, personnel and waste flow, is a 6 manufacturing room, Class 10,000, state of the art, multi-use clean room facility and has an associated product scale up and testing lab.

It has been designed to perform any type of manufacturing of cellular therapies, but due to its versatility, can be adapted to manufacturing of other products. For any product manufactured that will be used as a therapeutic, the GMP facility staff will help with establishment of Standard Operating Procedures (SOPs), Quality Control and Quality Assurance, storage and release of the product.

The facility has been approved by the FDA in a Type C meeting with the agency. Below is a link to the GMP facility video that CIRM produced about this facility one month ago.