The Clinical Cell and Vaccine Production Facility (CVPF) renders bench-to-bedside translational medicine a reality. Equipped with state of the art facilities, the CVPF manufactures cell and gene biotherapeutics and is accredited by the Foundation for the Accreditation of Cellular Therapy (FACT). Further, the CVPF is the only GMP (good manufacturing practices) compliant facility on campus and functions as an NCI approved Abramson Cancer Center (ACC) Shared Resource. As an ACC Shared Resource and Path and BioResources core facility, the CVPF supports numerous investigational new drug (IND) protocols. Current protocols target a variety of disease indications (primarily HIV, adult and pediatric cancers, and stroke); many more trials are in development and, once approved, will further expand the scope of diseases targeted for cell and gene therapy. For more information on current trials, explore our “Clinical Trials” page.
"The BACTEC blood culture system is a fully automated microbiology growth and detection system designed to detect microbial growth from blood specimens. The BACTEC™ FX and the BACTEC™ 9000 family of continuous monitoring blood culturing instruments offering performance, safety, reliability, ease of use, media quality and service. "
"The Elutra Cell Separation System operates differently than conventional centrifugation-based cell separators that separate cells depending primarily on their density. Instead, the Elutra system uses counter-flow centrifugal elutriation to separate the different cell types."
"The COBE 2991 Cell Processor provides operational reliability using automation for control and consistency:
• Variable spin times and speeds allow separation of components through centrifugation
• The agitate mode washes desired cell components with a choice of solutions
• Fluids or cells are expressed by the action of hydraulic fluid against a flexible membrane
A reliable laboratory tool, the COBE 2991 Cell Processor includes:
• Centrifuge unit with a flexible diaphragm
• Hydraulic system
• Operator panel with program board
• 5 pinch valves
• Red cell detector
• Secondary control panel
• Centrifuge cover interlock latch system
Achieving results through automation:
Automated cell processing with the COBE 2991 Cell Processor provides a high level of control for reproducible results:
• Three operations per cycle (start/spin, supernatant-out, agitate/wash-in)
• Precise programming of variable spin times adds automated accuracy and time-savings
• Programmable memory stores up to 10 protocols, with the ability to make changes during procedures for increased flexibility
• Three stop options: call the operator, or end the packed cells and re-suspended options
Separating with centrifugal technology:
• Separation of product components based on specific gravities
• Removal and/or collection of desired fraction
• Addition and agitation of wash solutions to remove unwanted cells, debris and fluids"
"The Multisizer 3 provides highly accurate particle counting and sizing information utilizing the Coulter Principle."
"The CliniMACS® System offers a flexible platform for processing and separation of virtually any cell type as well as customized processing protocols according to specific sample requirements. Unique reagents and tubing sets also allow for the transition of promising research applications into innovative cell therapy concepts. "
The Nova BioProfile 100 Plus bioanalyzer is a fully automated cell culture analyzer that tests for gluatamine, glutamate, glucose, lactate, ammonium, pH, sodium, and potassium and calculates osmolality.
The Clinical Cell and Vaccine Production Facility offers the following quality control and quality assurance services:
• Consultation with the Clinical Cell and Vaccine Production Facility
• Clinical Trial Start-up visit and Close-out visit
• Manufacturing review of dendritic cell final product by core director
• SOP development in consultation with staff
"The Facility Director and staff provide one-on-one consultations to investigators in planning and conducting clinical trials and assist in the preparation of grant applications to fund trials involving the core and for Investigational New Drug (IND) applications to the FDA. The Facility Director has demonstrated expertise in the Chemistry, Manufacturing, and Controls section of an IND and has prepared responses to multiple requests for information from the FDA."