#Nova bioprofile 400 series#

#Nova bioprofile 400 series#

In some cases, minor changes to the platform were required to optimize for a particular variant however, baseline conditions for the processes (cell line type, media & feed system, chromatography resins, and analytical approaches) remained constant, leading to successful transfer and manufacture of all four proteins in a cGMP facility. Nova manufactures a series of BioProfile В® automated cell culture analyzers for rapid analysis of key nutrients, metabolites, pH, gases, and cell density/cell viability. The platform development strategy was successfully implemented to produce four gp120 envelope protein variants.

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. A platform purification process was developed utilizing a mixed mode chromatography capture step, with ceramic hydroxyapatite and ion exchange polishing steps. The fed-batch cell culture production process was based on a commercially-available medium with harmonized process parameters across the variants. Cell lines were developed using the commercially available Freedom CHO DG44 kit (Life Technologies). 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.Дevelopment 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. Preclinical development of vaccine candidates is an important link between the discovery and manufacture of vaccines for use in human clinical trials.