Expression and purification of cGMP grade NY-ESO-1 for clinical trials Journal Article
| Authors: | Lowe, A. J.; Bardliving, C. L.; Huang, C. J.; Teixeira, L. M.; Damasceno, L. M.; Anderson, K. A.; Ritter, G.; Old, L. J.; Batt, C. A. |
| Article Title: | Expression and purification of cGMP grade NY-ESO-1 for clinical trials |
| Abstract: | NY-ESO-1 is a cancer testis antigen expressed in numerous cancers. Initial tests have shown its efficacy as a cancer vaccine, stimulating the body's own immune response against the invading tumor. To produce enough material for phase I clinical trials, a process using current good manufacturing practices to produce clinical grade material was developed and executed. His-tagged NY-ESO-1 was expressed in C41DE3 Escherichia coli under control of the T-7 promoter. NY-ESO-1 was produced in a 20 L fed-batch fermentation utilizing a pH-stat control scheme. The protein was then purified from inclusion bodies using a three-column process that achieved a yield of over 3.4 g and endotoxin below the detection limit of 0.005 EU/μg protein. © 2011 American Institute of Chemical Engineers. |
| Keywords: | clinical trial; immune response; antigens; cancer vaccine; detection limits; escherichia coli; diseases; vaccine; vaccines; phase i; g protein; ny-eso-1; experiments; fermentation; inclusion bodies; fed-batch fermentation; ct-antigen; purification; column process; control schemes; current good manufacturing practices; ph-stat |
| Journal Title: | Biotechnology Progress |
| Volume: | 27 |
| Issue: | 2 |
| ISSN: | 8756-7938 |
| Publisher: | American Chemical Society |
| Date Published: | 2011-03-01 |
| Start Page: | 435 |
| End Page: | 441 |
| Language: | English |
| DOI: | 10.1002/btpr.552 |
| PROVIDER: | scopus |
| PUBMED: | 21365782 |
| DOI/URL: | |
| Notes: | --- - "Export Date: 23 June 2011" - "CODEN: BIPRE" - "Source: Scopus" |
Altmetric
Citation Impact
BMJ Impact Analytics
Related MSK Work