Registration of APIs CMC information required for an IND
IND and NDA support Drug master files (DMF) filing
Application | T-cell assays, Immune monitoring, Antigen specific T-cell stimulation, T-cell expansion, Cellular immune response |
Purity | >70% (HPLC-MS) |
Areas of Interest | Control, AIDS, Infection |
Size | 1 vial containing 15 nmol ( 25μg) per peptide |
Format | Freeze dried in amber type glass vial |
NumberOfPeptides | 123 |
Organism | Human immunodeficiency virus (HIV) |
Specifications | Peptide scan (15mers with 11 aa overlap) |
Protein Name | Con B gag motif |
References | 1."A New Antigen Scanning Strategy for Monitoring HIV-1 Specific T-cell Immune Responses". Malnati et al., Journal of Immunological Methods (2011) (abstract) 2."Rebound of Residual Plasma Viremia After Initial Decrease Following Addition of Intravenous Immunoglobulin to Effective Antiretroviral Treatment of HIV". Mellberg et al., AIDS Research and Therapy (2011)) |
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