In mid-2015, we established our laboratory for the manufacture of ATMPs, in accordance with Good Manufacturing Practice requirements and procedures for the production of ATMPs approved by the Ministry of Health. We currently use this laboratory to produce ATMPs such as a dendritic cell vaccine for use in cancer immunotherapy and a T-cell product for the treatment of multiple sclerosis (the manufacturing of this product expected to start in 2018). We are the only GMP lab in the Baltic states involved in producing ATMPs.
The laboratory was established and the premises were equipped in accordance with the hygiene requirements of ISO 14644 standards. We also use the most advanced equipment available for the production, processing, multiplication, evaluation and storage of cells and their products.
Since 5 January 2016, we manufacture Dendritic cell vaccine in accordance with Permit No. 1 issued by the State Medicines Control Agency under the Ministry of Health of the Republic of Lithuania, allowing us to produce ATMPs for specific patients in line with a doctor’s prescription.