Caprylate viral deactivation
Inventors
Lebing, Wytold • Burns, Doug • Roth, Nathan • Hotta, JoAnn
Assignees
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Publication Number
US-9023797-B2
Publication Date
2015-05-05
Expiration Date
Abstract
Described herein are methods for inactivating viruses using caprylate in solutions containing albumin.
Core Innovation
The invention relates to methods of preparing albumin and inactivating viruses in a solution comprising albumin. The method includes adjusting the protein concentration of the solution to less than about 5%, adding caprylic acid (octanoic acid) or sodium caprylate, adjusting pH to about pH 5 or less, raising the temperature to about 27-30° C, and incubating for about 30 min to 120 min.
The document describes performing the treatment during albumin purification of pharmaceutical human albumin from plasma, including reference to replacing or avoiding acetone drying. It further characterizes integration with downstream unit operations such as ultrafiltration/diafiltration (UF/DF), filtration, formulation and bulking, and sterilizing/pasteurizing/filling.
In virus inactivation aspects, the document specifies a method of inactivating viruses in an albumin solution by adjusting protein concentration to less than about 5%, adding caprylic acid or sodium caprylate at greater than about 20 mM, raising the solution temperature to greater than about 20° C, and incubating, followed by filtering, performing ultrafiltration and diafiltration, formulating and bulking the solution, and sterilizing, filling, and pasteurizing the albumin.
Claims Coverage
Independent claims are identified for albumin preparation and for virus inactivation in an albumin solution, with the core sequence of protein concentration adjustment, caprylic acid/sodium caprylate addition, pH and temperature selection, and incubation, and with some independent claims further including downstream unit operations. The main inventive features across the independent claims are concentrated around the combined low-protein concentration, caprylate addition level, low pH, temperature elevation, and controlled incubation, followed by purification/finishing operations.
Protein concentration adjustment to less than about 5%
Adjusting the protein concentration of the solution to less than about 5%.
Caprylic acid or sodium caprylate addition
Adding caprylic acid (octanoic acid) or sodium caprylate to the solution, including embodiments where the concentration is about 20 mM to about 40 mM or about 20 mM, and embodiments where the concentration is greater than about 20 mM.
pH adjustment to about pH 5 or less
Adjusting pH of the solution obtained after caprylic acid or sodium caprylate addition to about pH 5 or less.
Temperature elevation to about 27-30° C or greater than about 20° C
Raising the temperature of the solution to about 27-30° C or raising the solution temperature to greater than about 20° C.
Incubation for about 30 min to 120 min or at least about 30 min to about 120 min
Incubating the solution for about 30 min to 120 min or incubating the solution for at least about 30 min to about 120 min.
Filtering, ultrafiltration and diafiltration, formulation and bulking, and sterilizing/filling/pasteurizing
Filtering the solution; performing ultrafiltration and diafiltration; formulating and bulking the solution; and sterilizing, filling, and pasteurizing the albumin.
Overall, the independent claims cover albumin preparation and virus inactivation that combine low protein concentration, addition of caprylic acid (octanoic acid) or sodium caprylate, pH adjustment to about pH 5 or less, elevated temperature, and controlled incubation, with embodiments that include subsequent filtration, UF/DF, formulation and bulking, and sterilizing/filling/pasteurizing the albumin.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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