What we do
The Vector Development and Production Facility (VDPF) at Roswell Park Comprehensive Cancer Center is a key component of the Division of Translational Immunology. The VDPF generates research and clinical-grade vectors that facilitate genetic engineering to target and better fight cancer cells. VDPF is equipped to produce cell lines, cell line clones, plasmid development and construction, research and scaling experiments to cGMP grade vectors for use in clinical trials.
The facility follows current good manufacturing practices (cGMP), producing compounds that meet specific requirements for identity, strength, quality, and purity, ensuring that the generated viral vector product is suitable for phase I and II clinical trials and compliant with the rigorous requirements set by Food and Drug Administration (FDA) guidelines. The facility manufactures gamma-retroviral and lentiviral vectors required by different investigators or sponsors. We plan to expand our development and production to oncolytic viruses such as vaccinia viruses soon.
Technology
Our facility works hand in hand with the research teams at Roswell Park and outside clients to assist in bringing novel ideas from the bench to the bedside. Our products can quickly be transitioned to the Therapeutic Cell Production Facility at Roswell Park for cell manufacturing and use in clinical trials.
The Vector Development and Production Facility:
- Develops appropriate quality-control assay to characterize the viral vectors
- Characterizes adherent and suspension cell line
- Develops and applies viral vector manufacturing processes for new vector products
- Translates viral vector manufacturing processes to conform to good manufacturing practices
- Provides production and storage of master cell banks (MCB), master virus banks and final clinical viral products in compliance with GMP
- Manufacture of cell lines and producer cell lines- from concept to final product: research grade, cGMP-comparable, and cGMP grade vector
Production scale:
- Manufacturing process and quality-control assay to produce and characterize small-scale vector production for research use
- Manufacturing process and quality-control assay to produce and characterize large-scale technical-grade vector production for toxicology and pharmacology studies
- Manufacturing process and quality-control assay to produce and characterize GMP-grade large-scale vector production for phase I/II clinical trails
- Coordinates clinical grade product safety testing required before products are released to the clinic
- Prepares and archives required GMP documentation related to the product manufacturing, product safety testing, facility testing and personnel training
We use various purification and concentration techniques including:
- Tangential Flow Filtration
- Ion exchange chromatography columns
- Ultracentrifugation
Testing capabilities include:
- VCN assays by digital droplet Polymerase Chain Reaction (ddPCR)
- Mycoplasma
- Endotoxin
- Transduction efficiency assays
- Biological Titration
- ELISAs
On-site release testing capabilities to include:
- RCR/RCL both genomic testing and biological testing
Using the resource
Investigators interested in the use of the facility should contact Joanna Stanson to discuss the project and services.
For quotes, pricing and inquiries, please contact Joanna Stanson 716-845-6580 or Cindy Bonura 716-845-3799.
The VDPF is located on the 6th floor of the Gratwick Basic Science Building. Hours of operation are weekdays, 9 a.m.-5:30 p.m.
Services
The VDPF provides comprehensive services for the development and production of large-scale lentiviral and retroviral vector products suitable for use in clinical trials. Since each vector is a custom project, prospective customers should discuss their project with Joanna Stanson for consultation of services and scale of production.
Instrumentation
- Tangential flow filtration and Diafiltration System (KMPI KROSFLO M.KROS and KROSFLO R IIii)
- Automated Hollow Fiber Bioreactor System
- BIORAD digital Droplet PCR system
- Gell Electrophoresis and Restriction Digestion Plasmid Testing Systems
- Automated Thawing and Couting Instrumentation
- Endosafe Endotoxin Instrument
- Synergy HTX Microplate absorbance reader
- PCR cycler instruments
- 6-foot Class II biosafety cabinets
- Double stacked CO2 Heracell incubators
- SORVALL centrifuges
- Liquid Nitrogen storage containers
- -80 C, -20 C freezers
- Inverted Phase Contrast Microscope
- Terumo Sterile Connecting Device
- Tube Sealer
- Electronic Key Card Access system
- ISENSIX Advanced Remote Monitoring System
- Magnahelic Gauges
Location and hours
Roswell Park Comprehensive Cancer CenterVector Development and Production Facility
Division of Translational Immuno-Oncology
Elm and Carlton Streets
Buffalo, New York 14263
Monday – Friday, 8:00 a.m. – 5:00 p.m.
Vector Development and Production Facility manufacturing
The VDPF manufactures clinical-grade retroviral and lentiviral vectors for Phase 1 and 2 studies. The manufacture of every batch of viral vector comprises of 3 phases:
- Phase 1: Assessment (sponsor requests and confirmation of plasmid identity)
- Phase 2: Small-scale manufacturing, testing and optimization
- Phase 3: Final product manufacture and release
Retroviral Vector Manufacturing Process
- Establishing a master cell bank (MCB)
- Master Cell bank certification
- Manufacture of cGMP retroviral vector supernatant
- Vector supernatant harvest and filtration
- Vialing and Storage
- Certification of final product
Lentiviral Vector Manufacturing Process
- Cell Plating of Certified 293T cells
- Transfection
- Transfection media removal
- Vector supernatant harvest
- Purification and concentration
- Vialing and Storage
- Certification of final product
Meet our team
The Vector Development and Production Facility is part of the Translational Immuno-Oncology Shared Resource (TIOSR). The TIOSR also consists of the Immune Analysis Facility and Therapeutic Cell Production Facility. The three facilities are designed to have all the components necessary for creating and delivering the newest immunotherapy treatment options. Few institutions in the nation have the facilities for pre-treatment, manufacturing and post-treatment of immunotherapies and gene therapy clinical trials. Our state-of-the-art facilities and expert researchers attract collaborative partnerships with academic institutions and private industry.
