Orsino Facility for Cell Therapy

The Philip S. Orsino Facility for Cell Therapy is a state-of-the-art facility offering Good Manufacturing Practice (GMP)-grade cell and tissue processing capabilities at the Princess Margaret Hospital. The facility is the result of a joint funding effort between the Canada Foundation for Innovation, the Ontario Innovation Trust, and the generosity of philanthropist Philip S. Orsino.

The Orsino facility provides the necessary infrastructure and support for the implementation of clinical-scale cell manufacturing. Areas of expertise include development of robust and reproducible standard operating procedures, scale-up and optimization.

The facility serves multiple purposes:
  • To support novel cell therapy research at University Health Network by providing GMP grade cell processing for investigator-initiated trials
  • To provide a full array of manufacturing, clinical and quality consulting services to external commercial and academic partners
The 2,900 sq. ft. Philip S. Orsino Cell Therapy Facility features:
  • three independent, class 10,000 clean rooms, each equipped with a biological safety cabinet, incubators, refrigerators, cell processing equipment and computer work stations
  • cryopreservation facility featuring multiple liquid nitrogen storage tanks
  • abundant support space for quality control/quality assurance
  • raw materials storage and quarantine spaces
  • administrative offices

For more information regarding the Philip S. Orsino Cell Therapy Facility, please visit http://www.uhnres.utoronto.ca/facilities/psoctf

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Orsino Facility Special Features

Surveillance

The facility is fully monitored through a computerized system linked to the hospital automation system. All vital aspects of the facility, such as particle counts and air pressure in each of the clean rooms, as well as freezer temperatures and incubator CO2 supply, are tracked 24 hours a day, 7 days a week as required by GMP regulations and which meet Food and Drug Administration (FDA) and European Medicines Agency (EMEA) standards.

An alarm system is in place to alert staff of any deviations from the set points. System measurements can be referenced from computer workstations throughout the facility, and records of all measurements are kept on file.

Air Handling

The facility has its own dedicated air handling unit, which is on emergency power. The air handler is equipped with a series of air filters and final HEPA filters. In addition, the air supply register in each clean room suite has a terminal HEPA filter.

Positive and Negative Pressure Rooms

One of the five clean suites is maintained at a negative pressure with respect to the remaining clean space. This suite is dedicated to high containment applications, such as those involving pathogens. The remaining clean rooms are maintained at a relative positive pressure, to minimize the possibility of product contamination.

Security

Access to the facility is restricted to authorized personnel by a coded card system. A second level of access further limits entry to the clean areas. The entire facility is monitored by a computer controlled security system.

REgenerative MEDIcine (REMEDI) Cell Expansion and Manipulation Facility (CEMF)

A 600 sq. ft. single-room class 10,000 clean room suite and adjoining non-clean room development laboratory space will be opened in April 2011 at the Max Bell Research Centre at the Toronto General Hospital, as part of a Canada Foundation for Innovation (CFI)-funded Regenerative Medicine (REMEDI) initiative led by Dr. Richard Weisel of the UHN Cardiovascular Medicine Program. This facility will act as a core resource and service the cell production needs of investigators at UHN primarily focused on regenerative medicine applications. The Facility will provide all of the autologous and allogeneic mesenchymal stromal cells for use in the clinical research protocols generated at UHN.

Center for Cell and Vector Production (CCVP), (2013)

As research programs within the UHN clinical programs including the Peter Munk Cardiac, Krembil Neuroscience, Musculoskeletal Health and Arthritis, Princess Margaret Cancer, Surgical and Critical Care and Transplant programs mature, a large number of research projects will progress to clinical implementation in the next 3 to 5 years.

In anticipation of this growing demand, we have received CFI funding for a 13,000 sq. ft. Ontario Regional Center for Cell and Vector Production (CCVP) which will be renovated and operational by the end of 2012. This central facility, located in at 620 University Avenue will act as a hub to make clinical grade cells and vectors for novel cell and gene based therapies to treat Canadian patients suffering from a variety of diseases. Participating institutions in the regional facility include Princess Margaret Hospital, Toronto General Hospital, Toronto Western Hospital, Sunnybrook Health Science Centre, St. Michael's Hospital, University of Western Ontario, McMaster University and the Ottawa Health Research Institute.

By having such a consolidated and centralized facility, we will be able to develop and implement a quality assurance program and provide consulting services on regulatory issues across the province ensuring that the highest standards of clinical research are carried out. The satellite facilities will not need to hire or develop similar quality and regulatory programs and can be serviced from the centralized facility instead. Importantly, as the program matures, the centralized facility may be able to provide other services including in-house release testing. With the construction of the CCVP and evolution of our program from a UHN-wide to an Ontario-wide service, we will implement a Quality Management Program to oversee all aspects of the clinical trials process, including GLP-grade translational research and GMP-grade cell and vector manufacturing.

Importantly, this regional, centralized, facility can pro-actively assemble the expertise and infrastructure in other satellite facilities in Ontario and concentrate them in core platforms which will enable researchers and clinicians to more effectively address the complex manufacturing, regulatory, and quality challenges involved in the clinical translation of cell and gene therapy protocols. By partnering with the facility, companies will not only gain access to the expertise of UHN researchers, but also the infrastructure provides a unique opportunity in Ontario and in Canada.

 
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