Abstract:
:A multi-component vaccine has been defined, which contains six different synthetic 24- to 32-amino acid lipopeptides derived from the sequence of HIV-1 proteins. The physicochemical properties of the lipopeptide components were compatible with multi-dimensional analysis, using RP-HPLC, Edman sequencing, electrospray mass spectrometry, and 2D-NMR. Detailed analysis of the impurity profiles led to the detection and evaluation of the relative proportions of most by-products: several contaminants resulted from the formation of acetylated fragments, transpeptidation reactions with succinimide or piperidide formation, or methionine and/or tryptophan mono-oxidations. The first batch to be produced underwent extensive pharmacotoxicological testings to confirm its safety; this vaccine candidate has now been used in phase I clinical trials. Despite the complexity of such multi-lipopeptide vaccines, our findings suggest the possibility of preparing a clear and precise assignment of by-products to toxicologically qualified impurities in the eventuality of a future production of several successive batches.
journal_name
Vaccinejournal_title
Vaccineauthors
Klinguer C,David D,Kouach M,Wieruszeski JM,Tartar A,Marzin D,Levy JP,Gras-Masse Hdoi
10.1016/s0264-410x(99)00196-6subject
Has Abstractpub_date
1999-09-01 00:00:00pages
259-67issue
3-4eissn
0264-410Xissn
1873-2518pii
S0264-410X(99)00196-6journal_volume
18pub_type
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