Stages
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1. Planning stage:
detailed study of the risks/problems/unforeseen events (product quality and safety, staff training, facilities, equipment, etc.) that may arise during the product manufacturing process.
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2. Set-up and escalation stage (under ISO 9001 standards):
adaptation of the product manufacturing protocol to the risks analyzed during the planning stage, equipment, facilities, final volume, among others.
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3. Product master documentation stage:
generation of the descriptive documents of the production protocols.
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4. Validation stage:
approval of the manufacturing processes and analytical methods used, as well as the qualification of the equipment.
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5. ATMP manufacturing stage:
production of the final product that will be used in patients.
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6. Monitoring and control stage:
batch review, monitoring and control of the product, reagents and other materials used.
Production of advanced therapies for clinical use
Creatio produces Advanced Therapy Medicinal Products (ATMPs) for clinical research under high quality standards in accordance with Good Manufacturing Practices (GMP) required by Spanish Agency for Medicines and Medical Devices (in Spanish, Agencia de Medicamentos y Productos Sanitarios, AMPS).
Creatio supports all aspects of production and analysis of clinical materials under current GMP. Creatio ensures that all projects are carried out with the application of the GMP and/or UNE-EN-ISO 9001, as well as the Creatio quality system.
The quality system provides extensive documentation of policies and procedures covering all aspects of facility operation, manufacturing and quality control analysis.
The resulting manufacturing batch records and associated documents provide full traceability that is critical for demonstrating GMP compliance and supporting Investigational New Drug (IND) and applications of the Investigational Device Exemption (IDE).
Process and development of documents
Creatio develops protocols and all the necessary documents for production under GMP conditions: Standard operating procedures, specification of cell sources, intermediate and final product, production of guides and process validation among others.
- Development of legal documentation: development of protocols for the production of ATMPs for clinical application, including gene therapy, cell culture, cryopreservation of stem cells and tissue engineering with a natural matrix or artificial.
- Develop procedures: provide full support for the clinical production procedure: cell culture and cryoprotection, cell vaccines, lentivirus production for ex vivo gene therapy and in vitro tissue manufacturing.
- Quality control: full product analysis and development, certification and analytical validation of methods to support the development process and release analysis under GMP.
- Quality certification: review the results and the release of the NCF batches, quality system support and warranty support in the audit.