Development of a platform-based approach for the clinical production of HIV gp120 envelope glycoprotein vaccine candidates.

Vaccine
Leslie S WolfeSigma Mostafa

Abstract

Preclinical development of vaccine candidates is an important link between the discovery and manufacture of vaccines for use in human clinical trials. Here, an exploratory clinical study utilizing multiple gp120 envelope proteins as vaccine antigens was pursued, which required a harmonized platform development approach for timely and efficient manufacture of the combined HIV vaccine product. Development of cell lines, processes, and analytical methods was initiated with a transmitted founder envelope protein (CH505TF), then applied to produce three subsequent gp120 Env (envelope) variants. Cell lines were developed using the commercially available Freedom CHO DG44 kit (Life Technologies). The fed-batch cell culture production process was based on a commercially-available medium with harmonized process parameters across the variants. A platform purification process was developed utilizing a mixed mode chromatography capture step, with ceramic hydroxyapatite and ion exchange polishing steps. A suite of analytical methods was developed to establish and monitor the Quality Target Profile (QTP), release and long-term stability testing of the vaccine products. The platform development strategy was successfully implemented to produce ...Continue Reading

References

Oct 15, 2009·Annual Review of Medicine·James A Hoxie
Apr 20, 2017·Current Opinion in HIV and AIDS·Max Medina-RamírezQuentin J Sattentau
Apr 5, 2018·Viruses·Yong GaoJamie F S Mann
Aug 14, 2018·Clinical Pharmacology and Therapeutics·Harriet L Robinson
Feb 15, 2020·AIDS Research and Human Retroviruses·Alexander BontempoMark J Cayabyab

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