An important step for patients with metastatic uveal melanoma.
The group of Jonas Nilsson at Gothenburg University recently finished their process validation on the manufacture of TILs for clinical trial at the GMP facility Cell and tissue laboratory, Sahlgrenska University hospital.
Rebecca Riise, scientist and project leader, reports; “Needle biopsies from liver metastatic uveal melanoma were collected and cultured for 18 days until growth of young TILs (y-TILs) could be confirmed. 1 million of these y-TILs were then expanded in the CliniMACS Prodigy bioreactor for 14 days, resulting in the final product TILs. The final product consisted of 1.4 billion cells, of which 98.5% were identified as CD3 + T cells. The product met the specification and the requirements of good manufacturing practice.
The application for clinical trial was submitted to the Medical Products Agency on the 15th of July.
The clincal trial will be performed at Sahlgrenska University hospital with Lars Ny in the role of Principal investigator and Sahlgrenska University hospital as the trial sponsor.
Kontakta gärna Rebecca om du vill ha mer info.
Rebecca Riise email@example.com