GMP Laboratory

GMP LABORATORY – WHAT IS IT?

Our GMP (Good Manufacturing Practice) laboratory is designed to comply with international regulations for the development of advanced medical therapy products and the preparation of cellular therapy applications. This specialized unit contains cleanroom technologies, HEPA filtration systems, and controlled production areas to ensure sterile conditions.

The laboratory enables the execution of high-security processes such as cellular products, stem cell applications, and biotechnological treatments. Quality control tests for these products are conducted according to international standards, and every stage is recorded meticulously.

WHEN IS IT USED?

GMP laboratory services are used for the production and quality control of cellular therapy products, stem cell applications, biotechnological treatments, and advanced medical therapy products. These services are essential for regenerative medicine, personalized cell therapies, and cutting-edge medical treatments.

MAIN APPLICATIONS AND TESTS:

• Cellular product culture: Stem cell and immune cell culture
• Biotechnological product development and process validation: Development and validation of biotech products
• Sterility tests and endotoxin analyses: Ensuring product safety and sterility
• Environmental monitoring: Air, surface, and equipment contamination testing
• Cell characterization: Viability, proliferation, differentiation analyses
• GMP quality management processes: Lot tracking, validation, risk assessment
• Stem cell processing: Isolation, expansion, and cryopreservation
• Exosome production: Isolation and characterization of exosomes
• Quality control testing: Purity, potency, and safety assessments

ADVANTAGES

• International GMP compliance
• Cleanroom technologies and HEPA filtration
• Sterile working conditions
• Advanced cellular therapy capabilities
• Comprehensive quality control
• Meticulous documentation and traceability