Consultation and Education to Establish Cell Therapy Centers

Clinical and research-based activities on stem cells have been growing extensively in recent years. The need for maintaining high international standards in the research environment is of great importance. Establishing centers for regenerative medicine requires technical knowledge of clinical grade cell production. It also demands expertise on rules and regulations of the field. SABZ has worked with an outstanding team of scientists in the field of cellular therapy who are experts in quality control and international standards. This group has established a history of training, research, education, and consultation. We provide these professional services to the customers:

 

Consultation for the establishment of cell therapy centers

  • Finding appropriate locations for cell therapy centers
  • Designing specific sections within the cell therapy center according to international standards
  • Evaluation of contractors at every step in the establishment of clean rooms and working environment.
  • Designing the lab bench organization
  • Consultation for purchasing laboratory supplies

 

Consultation for establishing quality control systems based on international standards to attain required certifications

  • Establishing quality control systems in the organizations based on international standards including ISO.
  • Consultation for obtaining required documents necessary for verifications and obtaining international ISO certificates.
  • Obtaining and updating standard operational procedures (SOP) for different sectors of the cell therapy center
  • Adaptation of all processes to Good Manufacturing Practice (GMP)

 

Consultation in design, registration, and establishing cell-based clinical trials

  • Consultation in designing stem cell-based clinical trials
  • Designing protocols for stem cell-based clinical trials according to GMP
  • Consultation for registration of clinical trials in international databases
  • Consultation for optimum production of cell-related products for clinical applications

 

Providing theoretical and practical training courses related to cell therapy

  • Basics of working in controlled environments and clean rooms
  • Basics of stem cell production for clinical applications
  • Introduction to GMP and its applications in regenerative medicine
  • Basics of quality management in biological sciences
  • Aseptic procedures and their application in regenerative medicine
  • Isolation, culture, and characterization of mesenchymal stem cells
  • Basics of tissue engineering

 

Providing support and initial leadership of cell therapy centers after set up

  • Scientific and technical support of stem cell centers from initial set up until the contract end date
  • Training the staff and providing supportive observation until the team is independently operational

 

These consultations have been provided to Shahed University and Tehran, Shiraz, Mashhad, Isfahan, and Tabriz Universities of Medical Sciences.