Abstract:
:Chagas disease due to chronic infection with Trypanosoma cruzi is a neglected cause of heart disease, affecting approximately 6-10 million individuals in Latin America and elsewhere. T. cruzi Tc24, a calcium-binding protein in the flagellar pocket of the parasite, is a candidate antigen for an injectable therapeutic vaccine as an alternative or a complement to chemotherapy. Previously, we reported that a genetically engineered construct from which all cysteine residues had been eliminated (Tc24-C4) yields a recombinant protein with reduced aggregation and improved analytical purity in comparison to the wild-type form, without compromising antigenicity and immunogenicity. We now report that the established process for producing Escherichia coli-expressed Tc24-C4 protein is robust and reproducibly yields protein lots with consistent analytical characteristics, freeze-thaw, accelerated, and long-term stability profiles. The data indicate that, like most proteins, Tc24-C4 should be stable at -80°C, but also at 4°C and room temperature for at least 30 days, and up to 7-15 days at 37°C. Thus, the production process for recombinant Tc24-C4 is suitable for Current Good Manufacturing Practice production and clinical testing, based on process robustness, analytical characteristics, and stability profile.
journal_name
J Pharm Scijournal_title
Journal of pharmaceutical sciencesauthors
Biter AB,Weltje S,Hudspeth EM,Seid CA,McAtee CP,Chen WH,Pollet JB,Strych U,Hotez PJ,Bottazzi MEdoi
10.1016/j.xphs.2017.12.014subject
Has Abstractpub_date
2018-05-01 00:00:00pages
1468-1473issue
5eissn
0022-3549issn
1520-6017pii
S0022-3549(17)30884-5journal_volume
107pub_type
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