Both resins can be introduced for the industrial purification of the r-HBsAg, attending to process specifications. The results showed that the Capto family had the highest critical velocities (Capto Adhere- 492, Capto Q- 477 cm/hr), whilst Sepharose CL-6B, Sepharose 4 Fast. The dynamic adsorption capacity of Cellufine MAX Q-hv resin (1.5 mg r-HBsAg/mL of resin) was higher than that for Capto Q (0.9 mg r-HBsAg/mL of resin), with more than 40 % of the chromatographic bed of both resins used is inefficiently. The maximum adsorption capacities of both resins were similar, with values between 1.5 and 1.8 mg of r-HBsAg/mL of gel. The Capto Q resin had an association constant 3.89 times higher than the Cellufine MAX Q-hv resin. Cellufine MAX Q-hv and Capto Q resins were assessed kinetically and thermodynamically, and their the adsorption behavior of r-HBsAg were predicted by Langmuir isotherms with a good adjustment (R2 > 90 %). This value was statistically different (p 0.05) to that of TMAE anion resin (Merck), currently in use for the industrial production process of the HeberBiovac HB® vaccine. The highest r-HBsAg recoveries were obtained with Capto Q resin (87.16 ± 1.34 %). In this work, the anion exchange chromatographic resins Cellufine MAX Q-hv from JNC Corporation (Japan) and Capto Q from GE Healthcare Life Science (USA) were evaluated for the purification process of the recombinant hepatitis B surface antigen (r-HBsAg), as active pharmaceutical ingredient. Anion exchange chromatography, adsorption isotherms, breakthrough curves, r-HBsAg.Ī thermodynamic and kinetic understanding of chromatographic separation is required for the design of the chromatographic process’ operating system.
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