Chalk River, ON – April 27, 2022 – Canadian Nuclear Laboratories (CNL), Canada’s premier nuclear science and technology organization, is pleased to announce that Chalk River Laboratories (CRL) has all the necessary infrastructure, equipment, procedures, and personnel to perform Good Laboratory Practice (GLP) compliant studies within its Biology Research Facility (BRF) and its Analytical Chemistry laboratories. This Good Laboratory Practices (GLP) facility-only recognition indicates that CNL is ready to accept GLP studies in these facilities. It is therefore a designation that brings exciting new opportunities to CNL. GLP recognition facilitates the acceptance of study results by national and international regulators, including Health Canada and the Food and Drug Administration (FDA) in the United States.
To comply with GLP principles, CNL has implemented rigorous GLP compliant procedures that cover the management and training of personnel, the management of infrastructures and equipment, the validation of computerized systems, and the conduct of studies. The designation will not only advance CNL’s leading radioisotope and pre-clinical capabilities, but it also opens new commercial opportunities and enables CNL to advance research partnerships.
“This latest achievement expands CNL’s opportunities in R&D including pre-clinical studies that are recognized by regulatory bodies like Health Canada or FDA pharmaceutical applications” commented Dr. Jeff Griffin, CNL’s Vice-President of Science and Technology. “It also opens new avenues for CNL in the growing radiopharmaceutical industry and strongly positions CNL’s capabilities to conduct studies under strict international standards. It was a tremendous amount of work to meet this standard, and I want to congratulate the team for this incredible accomplishment.”
Administered by the Standards Council of Canada, GLP recognition ensures a high degree of quality assurance and data integrity for laboratory research, and enables full traceability and curation of information. On the heels of this accomplishment , CNL will be building a larger team to pursue new commercial opportunities, which include studies conducted on behalf of pharmaceutical companies, government bodies, regulatory agencies, or other GLP recognized organizations. Pre-clinical and health studies is a phase conducted prior to human trials, and typically yields information about a drug’s safety, and toxicity in animal models.
CNL’s BRF is a 1,600 m2 state-of-the-art facility designed to support animal and animal tissue-based studies, and its capabilities to support radiation, radionuclide and carcinogen-based testing and experimentation are unique in North America. The BRF houses environmentally controlled, specific pathogen-free laboratories dedicated to biological research, which includes cell and molecular biology, histology and tissue processing, hematology, tissue culture and animal procedures. In the coming years, the BRF will increasingly serve as a key facility in CNL’s R&D related to targeted alpha therapy (TAT), a promising new cancer treatment that CNL is advancing.
“Being GLP compliant is highly complementary to Chalk River Laboratories’ current capabilities in producing Ac-225, one of the rarest medical isotopes in the world, and takes us one more step closer to becoming a major player who could advance the field of targeted alpha therapy” commented Ram Mullur, CNL’s Vice-President of Isotopes Business. “This achievement paves the way for CNL to conduct high quality pre-clinical studies for the radiopharmaceuticals industry”
CNL’s Biological Research Facility and Analytical Chemistry services are part of a broader series of laboratories and programs that CNL maintains in health studies and dosimetry services, including animal studies, isotope production and processing, targeted radionuclide therapies, and waste management solutions. For more information on CNL’s research in health sciences, including its Biological Research Facility, please visit www.cnl.ca/health.
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Director, Corporate Communications