GMP Compliance requirements posing challenges to Big Pharma Companies in Personalized Medicine
Commercial scale production of personalized drugs is a challenge as GMP Production involves cost due to regulatory requirements related to in process and post process controls and extensive documentation.Glioma Actively Personalized Vaccine Consortium (GAPVAC) is a 16 strong group of companies who are working together to bring novel class of fully personalized therapeutic cancer vaccines into trials for glioblastoma, a type of brain cancer. A special unit has been set up by GAPVAC along with the collaboration of University Of Tuebingen to deal with the problems of GMP certification of such drugs.
University of Tuebingen uses solid phase technology for peptide manufacturing to perform production at small scale meeting GMP conditions.