The Center of Excellence for Cellular Therapy (CETC) is a fully operational state-of-the art cGMP manufacturing facility for cellular therapies, including cancer immunotherapies, and is one of the biounits represented by C3i. Located within the Hospital Maisonneuve-Rosemont the CETC facilities have been validated and met expectations for the Canadian, EMA and FDA regulatory agencies. The CETC has received the highest certification from the Foundation for the Accreditation of Cell Therapies (FACT, USA) for “more than minimally manipulated cells” and is the only GMP validated operational center in Canada.
As the only fully validated GMP center in Canada to date and compliant with FDA and EMA regulations, we strive to be the leader in cGMP cell therapy products and services to both local and international industry, academia, and services providers
OUR FACILITIES
- We offer state-of-the art facilities
- 37 000 sq ft facility
- 14 GMP clean rooms
- Capacity for 100 employees
- EMA, FDA & Health Canada Compliant
- FACT Certified
- More than minimal manipulation
- Health Canada Cell-Tissue-Organ certification.
- Currently accommodates more than 400 cell grafts each year
- Grade A biosafety cabinets in grade B or grade C cleanrooms
- Focus on T-cell expansion against specific antigens
- Cell manipulations & transduction of immune cells
- Immunomagnetic cell separation (Miltenyi CliniMACS and Prodigy)
- Hematopoietic stem cell expansion
OUR ADVANTAGE OF BEING WITH HMR
- It has direct access to patients of interest for clinical trial conduct
- Clinical KOLs
- Offers support in Clinical Trial Application (CTA) to Health Canada, including preparation for PRE-CTA meetings, CTA writing and submission as well as support with other agencies.
OUR HISTORY
- Cell Therapy Laboratory initiated in 1990 by leading Canadian hematologist and C3i co-founder Dr. Denis-Claude Roy
- Canadian, Provincial and the HMR Foundation provided the financial support in establishing the CETC, which opened in Fall 2013 under the direction of Dr. Denis-Claude Roy
- As of July 2019, the CETC has produced for 8 clinical trials in cell and gene-edited cell therapy
The CETC has been the leading Canadian provider of cell expansion for stem cell transplantation with more than 200 performed annually.
OUR EXPERTISE
- Our clinical and cell manipulation expertise is paramount in haematology, cancer immunotherapy other anticancer approaches, as well as regenerative medicine stem cell therapy.
- We offer an excellent opportunity to conduct and supply multi-center clinical trials in North America
- CETC’s cell manufacturing capabilities include (i) translational expertise and “scale-up” solutions as well as (ii) GMP production and all necessary (iii) standardization for clinical development.
- includes the development, scale-up and CGMP clinical production of cells for Immuno-oncology therapies. (In capabilities section)
- Bone marrow/aphaeresis collection
- Autologous and allogeneic samples
- Cell treatment, separation and expansion
- Viral gene transduction of T cells
- CAR-T cell development and expansion
- Storage and transport
OUR CAPACITIES
cGMP MANUFACTURING
- Quality assurance
- Support for meetings with regulatory agencies
- Support for documentation submission and audits
- Navigating through the standards and needs of the various agencies.
- Knowledge of the regulations and guidance applying to clinical trials
- Validation, certification of equipment, supplies, processes
- Batch release and certification
- Storage
- Shipping logistic and distribution
- Production
- Validation
- QC testing
- Release testing and certification
- Batch recall
- QA and monitoring
CELL ISOLATION, CULTURE & CHARACTERIZATION
CELL SEPARATION, EXPANSION AND DIFFERENTIATION FACTORS
- T cell culture, stimulation, differentiation.
- DC differentiation, activation and loading
- NK cell culture
- Tumor cell isolation, culture, digestion
DEVELOPMENT OF COST-EFFECTIVE CELL CULTURE CONDITIONS
- Cell purity analysis
- Phenotype characterization
- Specification testing and functional validation
SCALE-UP PROCESS DEVELOPMENT AND OPTIMIZATION
- Technical transfer from customer conditions
- Comparability studies
- Bioprocess design, specification & testing
- Bioprocess scale-up & optimization (efficiency, closed system)
- Development of Cost-effective Strategies
- Process standardization and validation
- Critical parameter definition
- Stability studies
- Transport optimization