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MANUFACTURING OF

MEDICINAL PRODUCTS

   In mid-2015, we established our laboratory for the manufacture of advanced therapy medicinal products (ATMPs), in accordance with Good Manufacturing Practice (GMP) 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 (DCV) and cytokine induced cell killers (CIK) for use in cancer immunotherapy, a T-cell product for the treatment of multiple sclerosis and the preparation of stromal vascular fraction for cosmetology and traumatology. We are the only GMP lab in the Baltic states involved in production of ATMPs.

 

   The laboratory is established in clean rooms equipped in accordance with the requirements of the ISO 14644 classification, where we use the most advanced equipment for the production, processing, multiplication, evaluation and storage of cells and their preparations.

   We perform the production of ATMPs in accordance with the permits issued by the State Medicines Control Service (SMCS) under the Ministry of Health of the Republic of Lithuania, which allow the production of ATMPs for specific patients according to the doctor's prescription:

  • Stromal vascular fraction preparation manufacturing operations;

  • T cell preparation manufacturing operations;

  • Dendritic cell preparation manufacturing operations;

  • Cytokine induced cell killer preparation manufacturing operations.

   From 2018 we have also been issued a license to manufacture investigational advanced therapy medicinal products (iATMP) (see SMCS official website).

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