Viral Challenge Clinical Pharmacology Unit (CPU)
This clinical pharmacology offers a layout which is suited towards conducting early phase viral challenge studies.
Costa Mesa, CA
The Costa Mesa 25,000 sq. ft. clinical pharmacology Unit (CPU) has a strong focus on viral challenge studies. With 30 rooms able to house up to 60 subjects, Costa Mesa offers many distinct characteristics to ensure your study’s success.
- Certified on-site PBMC processing – by the CPT Method or the Ficoll-Paque method – is capable of producing up to 200 samples per day
- Lab equipped with multiple type II Biological Safety Cabinets
- Extensive experience in pediatric pharmacokinetic (PK) studies requiring subjects to stay in-house with their caregivers
- Pediatric-friendly facility
- 24/7 accommodations for specific client programs and protocols
- Crash carts in all units with medications/equipment to support a full code
- On-site pharmacy with its own clean room
- Dedicated recruitment call center focused on patient population studies
- Experienced staff capable of handling the complexities of working with these patient types and their families.
Other Notable Features/Capabilities
Houses the first ever commercial facility approved for conducting Viral Challenge Studies in the United States
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- Read our press release about the presentation of results of our Influenza clinical study at the Annual ICAAC meeting
In the wake of collaborations with the Stanford School of Medicine and various industry partners, WCCT Global has recognized the need to routinely isolate Peripheral Blood Mononuclear Cell (PBMCs) to characterize the human immune response to disease and various immune-targeted therapeutic agents.
PBMC isolation is one of WCCT’s core competencies. Through effective harvesting, processing, and analysis of PBMCs, researchers are able to evaluate immune responses to therapeutic agents and gain a deeper understanding of immune system function pre-dose, post-dose, and at other integral stages of testing.
Laboratory Overview
WCCT’s laboratory for PBMC isolation has worked closely with the Stanford School of Medicine to certify collection and isolation procedures. WCCT has performed direct comparisons of major techniques for PBMC isolation including those using Cell Preparation Tube (CPT) and Lymphoprep tubes in order to demonstrate the performance of various methods available to its clients. WCCT also works with clients to design and validate custom protocols to directly meet their needs.
To view WCCT’s process for PBMC isolation, watch this video.
- Five Class II Biological safety cabinets
- Seven refrigerated high-capacity centrifuges
- Multiple platforms for cell counting and viability assessment including:
- Nexcellom Cellometer K2
- Bio-Rad TC-20
- Two -80C monitored freezers
- Nexcellom Cellometer
- Bio-Rad T-20
- Capacity to process up to 200 blood samples per day
- Elderly
- Postmenopausal women
- Pediatrics
- HCV/HBV
- Renal
- Diabetes
- Asthma
- Allergy
- COPD
- Rheumatoid arthritis
- Hypertension
- CHF
- CAP/PAD
- Ophthalmology
- Obesity
- Influenza challenge studies
- Large, open phlebotomy areas
- ECG rooms with multiple stations
- Semiprivate subject rooms
- Various subject entertainment options
- Two spacious PK sample lab processing areas
- Large monitoring stations with phones and high-speed internet access
- Securely locked ambient and refrigerated drug storage room
- Two pharmacy dosing and storage areas with a USP 797 compliant cleanroom with ISO 5 Laminar Flow Hood (LFH)
- Secure medical records and CRF storage rooms
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