Figure 1. Removal of DNA from rHBsAg downstream manufacturing process. The process operations evaluated were: AP: supernatant of acid precipitation; PP: material from primary purification; NIE: elution of negative anion-exchange; IAF: elution of immunoaffinity chromatography; DS: elution of gel filtration chromatography; PIE: elution of positive anion-exchange; C-D: Concentration-diafiltration by Tangential Flow Filtration; GF: Gel-Filtration by High Performance Liquid Chromatography; API: Active Pharmaceutical Ingredient. Dashed line represents the acceptance limit for API, 10 pg per 20 μg rHBsAg.
(a) Total DNA in µg.
(b) Relative DNA in pg/dose HBsAg.