Non-Clinical Production and Quality Control Services

Related Core Facilities:

Friday 06/03/2011

The Biologics Production Facility offers a wide range of cell culture, protein purification, and associated support activities.  Although the resource has the capacity to provide clinical grade reagents it is also ideally suited to produce non-clinical research reagents at a scale and cost savings to the investigator.  The resource provides hundreds of these non-clinical services each year to Center investigators and a brief description is provided below

The most popular non-clinical service has been the pilot production program, which usually provides the investigator with from 2 to 10 mg of purified monoclonal antibody or similar protein for minimal cost from an existing cell line.  This service frequently supplies purified product in excess of the investigators needs, and at a very reasonable cost and turnaround time.  Pilot projects are useful to both the resource and the investigator in planning scaled production runs with target yields ranging from mg to gram quantities.  The pilot is offered on a one-time basis per cell line or clone.

The facility also offers a wide range of production services, such as large volume spinner flask and bioreactor bulk culture, custom purification, and process development.  For investigators requiring bulk cell production, cultivation and harvest of suspension cells are typically done at levels of 10-20 L, or more, providing investigators with harvested cell pellets beyond the scale generally available within their own laboratories.

Quality control services are also available.  Frequently requested assays include isotyping, endotoxin, sterility (USP), mycoplasma, RID, ELISA, SDS-PAGE, and IEF.  An added benefit is that most of these methods are validated as required for clinical studies.  Quality control also provides investigators with services such as environmental monitoring of critical laboratory areas/instruments, and can assist in establishing protocols to limit microbial and non-microbial contaminants.

For more information, please contact Ron Manger (email:; ph 667-5838).