Xintela signs agreement with Region Östergötland for GMP process development of cell therapy for burn patients
Xintela and Region Östergötland have signed an agreement where Xintela will develop and establish a GMP process to isolate and quality assure autologous (patient-own) skin cells for the treatment of burns. The agreement is worth SEK 3.6 million. The process will form the basis for an approval from the Medical Products Agency for the Burn Centre, Linköping University Hospital, to start a clinical study on burn patients. In the next step, Xintela will manufacture skin cell preparations from patient biopsies in Xintela’s GMP-approved production facility under a further agreement with Region Östergötland.
"It is very positive that we are now broadening the use of our GMP facility and our expertise to process development and production of other advanced drugs, so-called ATMPs (Advanced Therapy Medicinal Products). In the collaboration with Region Östergötland, we will use our experience in manufacturing ATMPs, to provide cell-based investigational drugs for clinical studies for an external customer, which brings revenues to Xintela. The availability of approved GMP facilities for ATMP manufacturing in Sweden is very low and it feels extra important that we can contribute to the supply of investigational drugs to patients where the medical need is very high", says Liselotte Theorell, Xintela Director Quality Management, QP.
"Region Östergötland and the Burn Center, Linköping University Hospital are very positive about a collaboration with Xintela and look forward to seeing the first Swedish ATMP (cell-based) product for the treatment of severe burns as a result of this collaboration. This can be a major step forward for the development of new treatment methods in the field of burn care and regenerative medicine in Sweden", says Consultant and Associate professor Moustafa Elmasry, Head of Research and Development Unit for skin and cultured cells, Department of Hand and Plastic surgery, Linköping University Hospital.