Safety and consistency in the manufacturing of TCR-T drug products represent a significant challenge due to the high variability of starting material. Final drug products must be of high quality, manufactured in the appropriate amount needed and, in a cost, and time-efficient way. Deep expertise and knowledge of manufacturing processes enable robust production of drug products. Standardized automated processes reduce the manufacturing procedure time while consistent quality control ensures a high quality of drug products.
Manufacturing TCR-T Drug products Abstracts
Helmholtz Alliance 2013, Asselheim
Marin V., Longinotti G. 2013. Status of GMP process development for TCR expression in lymphocytes. Helmholtz Alliance Asselheim, Germany.
Marin V., Longinotti G., Wieczorek A., Willde S., Mosetter B., Raffegerst S., Eckl J., Ellinger C., Frankenberger B., Leisegang M., Uckert W., Spranger S., Uharek L., Schendel D. 2013. Setting up of a GMP-compliant method for the production of human TCR-transduced T cells for the clinical testing. Helmholtz Alliance Asselheim, Germany.