Analytical Pharmacology
The Analytical Pharmacology Shared Resource (AP-SR) provides comprehensive analytical and consultative services to COHCCC Members in a GLP-compliant environment. The AP-SR assists with the design and implementation of pharmacokinetic, pharmacodynamic, and biomarker correlative studies for clinical and preclinical investigations of small molecules and biologic agents. The AP-SR also provides GLP-compliant quality control release testing of CC manufactured cell therapies.
Services include:
- initial consultation on research projects;
- study design and protocol review, including collaboration with biostatisticians;
- development, implementation, and validation of analytical methods;
- sample acquisition, tracking, and storage;
- sample analysis (e.g., LC-MS/MS, ICP-MS, HPLC, Luminex, ELISA, FACS, and qPCR);
- QC final product release testing (e.g., mycoplasma, endotoxin, cell potency and identity, cell counting and viability, cell specific lysis);
- pharmacokinetic programming and data analysis; and
- participation in collaborative writing for manuscripts and grant proposals. The AP-SR is directed by Dr. Timothy Synold and is supported by 13 FTEs.
Specific Aims of AP-SR:
Aim 1. Provide support for clinical investigators and trainees requiring expertise in pharmacokinetics, pharmacodynamics, and molecular correlative laboratory studies.
Aim 2. Facilitate preclinical cancer-focused research to support basic, translational, and population scientists and trainees who require analytical services.
Aim 3. Perform GLP-compliant quality control (QC) in-process and final product release testing and provide correlative analyses in support of the COHCCC Cellular Therapy Program.
Members Utilization by % Revenue 2017–21: 93.8 Total (4.3 MCBC, 25.3 DCT, 22.2 CI, 35.8 HM, 6.2 CCPS)
Publications by Members: 44, 12 with Impact Factor >10
Grants Supported: 52 Total (9 CIRM, 1 DoD, 2 LLS, 20 NCI of 34 NIH ( 20R01, 4U01))
The Analytical Pharmacology Core Facility (APCF) facilitates collaborative research between basic scientists and clinicians through extensive pharmacology expertise and analytical services. It conducts pharmacokinetic and pharmacodynamic studies for clinical trials and peer-reviewed preclinical studies.
Core services include:
- Initial consultation on research projects
- Study design and protocol review
- Development, implementation and validation of analytical methods.
- Sample analysis (LC-MS/MS, ICP-MS, HPLC, Luminex, ELISA and FACS).
- Pharmacokinetic programming and data analysis
- Sample processing, tracking and storage
- GLP-compliant release testing (endotoxin and mycoplasma)
- Participation in collaborative writing
The APCF currently occupies 3300 square feet of space in the Shapiro building, including a 275-square-feet tissue culture area, a 275-square-feet area for qPCR and ELISA, and a 250-square-feet room for liquid nitrogen and -80°, and -20° C storage, and a 200-square-feet room for Luminex equipment. Additional freezers for long-term sample storage are located in the Beckman Center Freezer Farm. Laboratory operations are guided by GLP principles of operation, with all requisite equipment being 21 CFR part 11 compliant. APCF includes state-of-the-art equipment for monitoring immune responses to cancer therapy and has been processing serum and PBMCs for preclinical and clinical investigators for more than 10 years. APCF has performed over 500 Luminex assays and is a part of the NIH-NIAID-DAIDS external quality-assurance program oversight laboratory program. During the last performance review, APCF received 98.9 points (out of 100) for Luminex EP4, which corresponds to “Excellent,” the highest possible performance rating.
- Initial consultation on research projects
- Study design and protocol review
- Development, implementation and validation of analytical methods.
- Sample analysis (LC-MS/MS, ICP-MS, AAS, GC/MS, HPLC, Luminex, ELISA and QPCR).
- Pharmacokinetic programming and data analysis
- Sample processing, tracking and storage
- GLP-compliant release testing (endotoxin and mycoplasma)
- Participation in collaborative writing
Current pricing can be found on iLab Solutions.
Vivi Tran, M.S., Quality Control Manager
Vivi has over 15 years of experience in immunoassay development and qualification and GLP/GDP/GMP-compliant operations. She maintains the laboratory infrastructure in a GLP-compliant manner, including the development and execution of SOPs in support of all aspects of the laboratory.
Dauh-Lian Chi, M.S., Immunochemist
Dauh-Lian worked as a Quality Control Associate and QC Manager at Baxter Bioscience before joining the City of Hope and has over 10 years of experience in immunoassay development and qualification and GLP/GDP/GMP-compliant product release testing. She is responsible for developing and performing ELISA, flow cytometric, and IsoLight assays within the core.
Ye Feng, Ph.D., Manager, Analytical Chemistry
Aparna Krishnan
Frank Xia
Miguel Guzman
Contact the Team
Acquired in 2017, the Xevo-TQXS Ultima is Waters most-sensitive, bench-top tandem quadrupole mass spectrometer.
Acquired in 2003, the Waters Quattro Ultima is a quadrupole-hexapole-quadrupole mass spectrometer with a mass-to-charge range of 4,000 Da, with unit resolution across the entire mass range.
Acquired in 2007, the Waters Quattro Premier XE is a compact, bench-top triple-quadrupole tandem mass spectrometer.
Acquired in 2010, QTRAP 5500 is a high-sensitivity, bench-top, hybrid triple-quadrupole, and linear-accelerator-trap mass spectrometer designed for LC-MS/MS analyses.
Acquired in 2015, the Agilent 8800 is the first ICP triple-quad ever produced. The 8800 combines superior matrix tolerance and a 10x dynamic range through the power of MS/MS for interference removal.
The core has two FlexMap3D instruments available to support researchers. These represent Luminex’s most advanced and versatile multiplexing immunoassay platform.
In a given year, City of Hope conducts more than 400 clinical trials enrolling more than 6,000 patients.
City of Hope is focused on basic and clinical research in cancer, diabetes and other life-threatening diseases.