Philip S. Orsino Cell Therapy Facility

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. The Facility is led by Director Hans Messner.
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
Contacts
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. The Facility is led by Director Hans Messner.
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
Contacts