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 |
Size | 1 vial containing 15 nmol ( 25μg) per peptide |
Format | Freeze dried in amber type glass vial |
NumberOfPeptides | 20 |
Organism | Epstein-Barr virus (HHV-4),Influenza A |
Specifications | Defined HLA class I-restricted T-cell epitopes |
Protein Name | Selected proteins |
References | 1."A Panel of MHC class I Restricted Viral Peptides for Use as a Quality Control for Vaccine Trial ELISPOT Assays". Courier et al., Journal of Immunological Methods (2002) |
2. C-Peptide replacement therapy and sensory nerve function in type 1 diabetic neuropathy
4. Autoinhibition and phosphorylation-induced activation of phospholipase C-γ isozymes
5. Implications of ligand-receptor binding kinetics on GLP-1R signalling
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