Quality Control Testing Laboratory

The GMP Quality Control Testing Laboratory (QCTL) is a core housed in the Institute for Regenerative Cures on the Sacramento campus.  The QCTL provides fee-for-service product release testing for products manufactured by industry clients, as well as for the UCDH GMP Facility and other university researchers. The staff consists of licensed Clinical Laboratory Scientists, a hospital lab technician, and a Medical/Laboratory Director.  The ongoing quality system of the laboratory includes participation in peer comparison studies for control materials, and proficiency testing via College of American Pathologists blind samples.

Testing available:

Test Descriptions:

Sterility Culture 

Examining final products for contamination is a practical measure for patient safety.  Per USP <71>, final formulation is inoculated into each of two media (thioglycollate and soybean-casein digest).  Total submission volume shall be agreed upon based on USP guidelines.  Sample is incubated for 14 days to conclude a result of “no growth.”  If the sample is turbid, it will be subcultured for a final read no less than 4 days later.  Inhibition Testing is needed for all new products.

Inhibition Testing (Bacteriostasis/Fungistasis) 

Per USP <71>, all products submitted for sterility culture need to be assessed for inhibition to ensure microbes can be detected in products if they are present.  This testing is only needed once per product. This testing requires final formulation be inoculated with a suspension of microorganism (S. aureus, B/P. vulgatis, P. aeruginosa/paraeruginosa, C. albicans, A. brasiliensis, B. subtilis).  Each microbe inoculation contains less than 100 CFU.  An acceptable result is “growth.”  Testing is typically complete within five days.  Please notify the QCTL a week before sample submission. 

Gram Stain 

This testing is available as STAT depending on staff availability for an extra fee.  Please allow up to four hours for results after STAT sample submission.  This testing requires 500uL sample volume.

Endotoxin 

This testing is available as STAT depending on staff availability for an extra fee.  Please allow up to two hours for results after STAT sample submission.  This testing requires at least 500uL sample volume.  The Endosafe NexGen PTS reader is used.  Results are typically released on the same certificate of analysis if both gram stain & endotoxin are ordered.  Please provide an endotoxin limit calculated for your product; calculation guidance is available in USP <85>.  Inhibition & Enhancement Testing is needed for new products.

Endotoxin Inhibition and Enhancement Testing 

This is a one-time test for agents that could enhance or inhibit endotoxin detection in the product sample submitted.  At least 500uL are needed for this test; ideally more sample is better if multiple sample preparations need to be tested.  The Endosafe NexGen PTS reader is used.

CD34 Flow Cytometry 

The QCTL provides clinical CD34+ cell analysis utilizing the International Society of Hematotherapy and Graft Engineering (ISHAGE) gating strategy.  The lab performs flow cytometry and is licensed by the state of California for clinical patient testing with a maintained CLIA certificate of compliance for CD34 enumeration. This test is validated for whole blood in EDTA tubes, apheresis product with heparin or ACD-A, and bone marrow with heparin or ACD-A.  STAT testing is available for this test depending on staff availability for an additional fee.  Other sample types require test development and validation.

CD3 Flow Cytometry 

This test is validated for apheresis product with heparin or ACD-A.  STAT testing is available for this test depending on staff availability for an additional fee.  Other sample types require test development and validation.

Viability Flow Cytometry

Viability is performed as a part of flow cytometry testing using 7AAD viability dye.

Automated Cell Count

Total nucleated cells are reported.  Testing is performed with a Sysmex XN-330 and requires at least 500uL.

Custom Test

Other testing may be performed in the QCTL after development.  These tests are typically flow cytometry panels that have been developed after collaboration with the client and tested with final formulation in parallel with another lab before becoming a test of record. Our clinical testing is required to follow the Clinical Laboratory Improvement Amendments (CLIA) of 1988, as outlined in 42 CFR 493.  Validation of clinical trial product testing may be in progress during the trial with the goal of complete validation.  It is necessary to provide additional final formulation to perform studies on antibody titrations, sample stability, linearity, precision, accuracy, sensitivity, and/or correlation.

Have questions? Drop us a line!

Contact: QCTL@health.ucdavis.edu