Clinical Trials and Preclinical Infrastructure Asset Map - Life Sciences

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306 BRITISH COLUMBIA APPENDIX 12. PRECLINICAL STUDIES SERVICE ORGANIZATIONS Company/ URL Contact Information Therapeutic Expertise and Types of Services Structure Number and Type of Staffing BCCA Investigational Drug Program (IDP) www.bccrc.ca/at/focus_investigationaldrugprogram.html B.C. Cancer Agency Research Centre 675 West 10th Avenue Vancouver, B.C. V5Z 1L3 Tel : 604-675-8000 Head: Marcel Bally Tel :604-675-8020 mbally@bccrc.ca Clinical Trials Support Services Contact: Dawn Waterhouse Tel : 604-675-8022 dwater@bccrc.ca Provides facilities for the pharmaceutical formulation, manufacturing and pre-clinical testing of new parenteral drugs for Phase I and II clinical trials. Complies with Good Manufacturing Practice and Good Laboratory Practice. It has a mandate to develop promising new therapeutic agents for new anticancer agents introduction into clinical trials. IDP operates a pharmaceutical GMP clean room facility for manufacturing and packaging of parenteral drug products for Phase I and Phase II clinical trials, primarily in the cancer sector; and also non-cancer therapeutic applications. Non-Clinical Safety Studies/Toxicology Conducted by IDP through the B.C. Preclinical Research Consortium; compliant with OECD Principles of Good Laboratory Practices GMP Formulation and Manufacturing Services Services range from core batching and filling activities to comprehensive development, validation, production and documentation projects. Core services provided by Investigational Drug Program for all final drug production runs: • Process development and validation • Material control and inventory documentation •Vendor qualification • Master formula/batch record design and implementation •Batch production to 10 litres or 1500 vials/day •Facility cleaning and environmental monitoring •Sterilisation / depyrogenization of equipment and packaging materials •Basic batching processes and formulation •Product sterilization through aseptic filling of final drug product Vial sizes from 1 ml to 50 ml • Comprehensive Quality Management System • Product inspection and labeling IDP is a business unit within the BCCA, and is part of the Advanced Therapeutics Department. 16 employees based in Vancouver Animal technicians: 5 Study Directors: 2 Tissue Culture Manager: 1 Quality Management/ Documentation: 3 GMP Manufacturing: 2.5 FTE plus 1 FTE co-op student Analytical: 2 Clinical trials support: 2 plus 1 co-op Types of Clients Predominantly services B.C. science community;. with some clients in Canada, North America and Europe. Clients include SMEs, Hospitals, Institutions, University Med schools, and small operations requiring CT operations, manufacturing, and services Regulatory Qualifications Animal facility and testing areas compliant with: OECD GLP practices cGMP Clean Room Facility complies with: US FDA 21 CFR Parts 210 and 211 Health Canada HPFBI GMP guidelines.
CLINICAL TRIALS AND PRECLINICAL INFRASTRUCTURE ASSET MAP 307 Company/ URL Contact Information Therapeutic Expertise and Types of Services Structure Number and Type of Staffing Clinical Trials Support Services: • Handling & processing of all bodily fluids • PK sample processing 24 hours/day, 7 days/week • Pharmacodynamic sample processing • Pharmacogenomic and pharmacogenetic sampling • PBMC preparation • Documentation, storage and shipment of samples • Attendance at site initiation visits • Class IIA Biosafety cabinets (certified) • Class IIB Biosafety cabinets (certified) • Restricted access laboratory Regulatory interaction/compliance and facilitation for all levels of studies Types of Clients Regulatory Qualifications
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Clinical Trials and Preclinical Infrastructure Asset Map - Life Sciences

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