Process development and production of cGMP grade Melan-A for cancer vaccine clinical trials Journal Article
| Authors: | Bardliving, C. L.; Lowe, A. J.; Huang, C. J.; Manley, L.; Ritter, G.; Old, L.; Batt, C. A. |
| Article Title: | Process development and production of cGMP grade Melan-A for cancer vaccine clinical trials |
| Abstract: | Melan-A is a cancer testis antigen commonly found in melanoma, and has been shown to stimulate the body's immune response against cancerous cells. We have developed and executed a process utilizing current good manufacturing practices (cGMP) to produce the 6 times-His tagged protein in C41DE3 Escherichia coli for use in Phase I clinical trials. Approximately 11 g of purified Melan-A were produced from a 20 L fed-batch fermentation. Purification was achieved through a three column process utilizing immobilized metal affinity, anion exchange, and cation exchange chromatography with a buffer system optimized for low-solubility, high LPS binding capacity proteins. The host cell proteins, residual DNA, and endotoxin concentration were well below limits for a prescribed dose with a final purity level of 91%. © 2013 Elsevier Inc. All rights reserved. |
| Keywords: | process development; ct-antigen; cgmp; melan-a; mart-1 |
| Journal Title: | Protein Expression and Purification |
| Volume: | 92 |
| Issue: | 2 |
| ISSN: | 1046-5928 |
| Publisher: | Academic Press Inc., Elsevier Science |
| Date Published: | 2013-12-01 |
| Start Page: | 171 |
| End Page: | 182 |
| Language: | English |
| DOI: | 10.1016/j.pep.2013.09.002 |
| PROVIDER: | scopus |
| PUBMED: | 24045055 |
| DOI/URL: | |
| Notes: | --- - "Export Date: 2 December 2013" - "CODEN: PEXPE" - "Source: Scopus" |
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