Global Manufacturing Of Car T Cell Therapy

Levine and james e miskin and k.
Global manufacturing of car t cell therapy. Ecollection 2017 mar 17. Global manufacturing of car t cell therapy article levine2017globalmo title global manufacturing of car t cell therapy author b. 3cell and gene therapies unit novartis pharmaceuticals corporation east hanover nj 07936 usa. Authors bruce l levine 1 james miskin 2 keith wonnacott 3 christopher keir 3 affiliations 1 department of pathology and.
Levine 1 james miskin 2 keith wonnacott 3and christopher keir 1department of pathology and laboratory medicine university of pennsylvania philadelphia pa 19104 usa. Accepted manuscript global manufacturing of car t cell therapy bruce l. Compliance of the chimeric antigen receptor t cell manufacturing process with global regulatory requirements becomes a topic for extensive discussion. Global manufacturing of car t cell therapy.
Global manufacturing of car t cell therapy. Levine james miskin keith wonnacott christopher keir pii. Global manufacturing of car t cell therapy. We are currently manufacturing the cd19 car t cell therapy ctl019 in a way that will streamline the process of using the therapy globally.
Global manufacturing of car t cell therapy mol ther methods clin dev. Levine and james e miskin and k. 3 and christopher. Additionally the challenges of taking a chimeric antigen receptor t cell manufacturing process from a single institution to a large scale multi.
Global manufacturing of car t cell therapy article levine2017globalmo title global manufacturing of car t cell therapy author b. However a number of manufacturing and regulatory challenges need to be considered when attempting to bring a cellular therapy with a complex manufacturing process to a larger international patient population. 53 if the ratio of t cell subsets becomes an important factor in car t cell therapy manufacturing protocols may need to be altered to include the extra purification steps necessary to administer car t cells in a. Review global manufacturing of car t cell therapy bruce l.