CN54gp140: product characteristics, peclinical and clinical use - recombinant glycoprotein for HIV immunization

Methods We have expressed the soluble form of the HIV envelope of the C/B’ strain 97/CN/54 in CHO cells. The production process consisted of a large-scale fed-batch fermentation, an antibody-based affinity chromatography plus additional purifying steps. CN54gp140 was extensively characterized for purity and identity. All glycosylation sites were characterized by mass spectrometry. Immunogenicity and safety were evaluated in mice, rabbits, minipigs, sheep as well as non-human primates. The antigen was formulated for clinical phase I studies in Tris buffer (MUCOVAC I, HIVIS07) in HEC gel (MUCOVAC I) as well as chemically conjugated to hsp70 (MUVAPRED).