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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%.
AuthorsCameron L Bardliving, Adam J Lowe, Chung-Jr Huang, Laura Manley, Gerd Ritter, Lloyd Old, Carl A Batt
JournalProtein expression and purification (Protein Expr Purif) Vol. 92 Issue 2 Pg. 171-82 (Dec 2013) ISSN: 1096-0279 [Electronic] United States
PMID24045055 (Publication Type: Journal Article)
CopyrightCopyright © 2013 Elsevier Inc. All rights reserved.
Chemical References
  • Cancer Vaccines
  • MART-1 Antigen
  • Recombinant Fusion Proteins
  • polyhistidine
  • Histidine
Topics
  • Biomedical Research
  • Cancer Vaccines
  • Chemistry, Pharmaceutical
  • Chromatography, Ion Exchange
  • Fermentation
  • Histidine (chemistry, genetics, metabolism)
  • MART-1 Antigen (chemistry, genetics, metabolism)
  • Protein Stability
  • Recombinant Fusion Proteins (chemistry, genetics, isolation & purification, metabolism)
  • Reproducibility of Results

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