ATMP is a new category of medicinal products produced on the basis of gene therapy, somatic cell therapy or tissue engineering. A few years ago these products were made in the ordinary, traditional labs, but because of the changes in law, according to GMP production of ATMP has to take place in clean room.
It means, for example, cells for transplant need to be prepared in the same manner as sterile dosage forms, e.g., ampoules. Laboratories which want to produce ATMP must create tissue / cells banks. The main reason for creating a new banks is a strong development of regenerative medicine, as well as the search for new therapies based on cells (especially stem cells)
- the area of our training within the ATMP
- planning and designing the clean room
- creating a quality system at the tissue and cells banks
- preparing the necessary documentation with the registration process
- organization of work in the clean room during the processing cells
- adjusting a process of cell culture to the requirements of GMP
Each training and choice of topics for discussion are individual and designed to meet the needs of your company and business. Our training courses include theoretical and practical part.