The Philip S. Orsino Cell Therapy Facility is a state-of-the-art facility offering Good Manufacturing Practice (GMP) grade cell and tissue processing capabilities.
Overview
- Provides the necessary infrastructure and expertise to enable development of novel cell therapy protocols
- Can accommodate novel Phase I studies through to advanced stage trials
- Provides consultation services to help prepare clinical trial applications (CTAs) for submission to Health Canada
Available Equipment
- Three independent, class 10,000 clean rooms are available and each is equipped with a class 100 biological safety cabinet, incubators, refrigerators, cell processing equipment and computer work stations
- Cryopreservation facility featuring multiple liquid nitrogen storage tanks
- Raw materials storage and quarantine space
Services
- Manufacturing services including: isolation and preparation of blood and marrow stem cells, separation of cells with specific function, in vitro cell expansion and manipulation, genetic manipulation of cells, cryopreservation and long-term storage
- Quality Control (QC) and Quality Assurance (QA) services, including development and qualification of assays for release of final cell and gene therapy products and in-process testing for validation of critical processes
- Consulting: review and development of standard operating procedures (SOPs), clinical protocols, regulatory compliance, and QC/QA on cell products
- Regulatory support, including review of Research Ethics Board submissions and clinical trial applications to Health Canada
Using the Facility
- Open to academic and corporate users
- Due to our limited capacity, a selection process by the Scientific Advisory Board is in place
- New users should complete the Application form
Training
- GMP training available for collaborative projects
- Introduction to clinical trials workshops conducted annually
Usage arrangements
- Fee-for-service or collaborative agreements
Quick Links
- Webpage (link is external)
- Application Form
Floorplan
