Method for purification of albumin

Inventors

Seo, Jin SeogMiller, David

Assignees

Evolve Biologics Inc

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Publication Number

US-11427613-B2

Patent

Publication Date

2022-08-30

Expiration Date


Abstract

A method for the purification of albumin from plasma is described. The method comprises (a) contacting the plasma with sodium caprylate (NaCP) at an amount dependent on total protein concentration and the ratio of NaCP to total protein in the plasma, (b) heating the plasma at a near neutral pH range, and (c) separating the albumin from non-albumin-phase. The said method provides for a high yield and purity albumin solution.

Core Innovation

The invention relates to a method for purifying albumin from plasma by contacting the plasma with sodium caprylate (NaCP). The NaCP is used in an amount between 0.8 and 1.3 mmol NaCP per gram of total protein in the plasma, and the total protein in the plasma is in a concentration between 50 and 80 g/L.

After contacting with NaCP, the plasma is heated at a temperature between 60 and 70°C. The heating is followed by separating the albumin from the non-albumin phase.

The method recovers at least 75% of albumin from plasma. The disclosure further refines separation and processing conditions, including embodiments that separate albumin using depth filtration and tangential flow filtration (TFF), including cassette or hollow-fibre configurations, as well as embodiments that separate albumin by precipitating non-albumin protein and lipid impurities.

Additional embodiments refine processing by including pH adjustment and clarification/filtration options, with dependence on parameters described in the disclosure such as the NaCP/total-protein ratio and total protein concentration, and with reported improvements in albumin purity after pH adjustment followed by clarification/filtration.

Claims Coverage

The independent claim defines a NaCP-contacting, controlled-heating, phase-separation albumin purification method with quantitative constraints. It requires four main inventive features: specified NaCP amount per gram of total protein, specified heating temperature range, separation of albumin from a non-albumin phase, and quantitative albumin recovery, further constrained by a total protein concentration range.

NaCP contacting with defined NaCP per total protein

Contacting the plasma with sodium caprylate (NaCP), wherein the amount of NaCP is between 0.8 and 1.3 mmol NaCP per gram of total protein in the plasma; and wherein the total protein in the plasma in (a) is in a concentration between 50 and 80 g/L.

Defined near-heating at 60 to 70°C

Heating the plasma at a temperature between 60 and 70°C.

Albumin separation from a non-albumin phase

Separating the albumin from the non-albumin phase.

At least 75% albumin recovery

Recovering at least 75% of albumin from plasma.

Overall claim coverage centers on controlled NaCP contacting tied to total protein concentration, heating within 60–70°C, separation into an albumin fraction versus a non-albumin phase, and achieving at least 75% albumin recovery, with dependent claims further specifying separation techniques and additional processing constraints.

Stated Advantages

Achieves recovery of at least 75% of albumin from plasma.

Documented Applications

No documented applications found

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