IP Library Patent Application 18616877
Patent Application
App. No. 18/616,877

ALPHA SYNUCLEIN SUBSTRATES AND METHODS FOR MAKING AND USING THE SAME

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Patent No.
US None
App. No.
18/616,877
Abstract

An expression vector is provided for production of human alpha-synuclein (αS) protein or a conservative variant thereof that exhibits a decreased tendency to self-aggregate in an αS seed amplification assay (SAA). The expression vector comprises a nucleic acid sequence coding for human αS protein or a conservative variant, the nucleic acid sequence comprising codons that have been optimized to produce human αS protein or a conservative variant when expressed by a host cell such as E. Coli . The codons have been optimized to avoid amino acid misincorporation in the expressed protein. Methods for purification of the expressed protein are also provided.

Claims (43)

1 . A nucleic acid sequence having at least 95% identity with SEQ ID NO: 1, excluding SEQ ID NO: 3.

2 . An expression vector for production of a protein comprising SEQ ID NO: 6, the expression vector comprising a nucleic acid sequence comprising at least 95% identity with SEQ ID NO: 1, excluding SEQ ID NO: 3.

3 . The expression vector of claim 2 , further comprising a nucleic acid sequence having at least 95% identity with SEQ ID NO: 2, excluding SEQ ID NO: 4.

4 . A protein comprising SEQ ID NO: 6, prepared using the expression vector of claim 2 .

5 . A method for preparing a protein comprising SEQ ID NO: 6, the method comprising:

transforming into an enterobacterial host cell an expression vector comprising a nucleic acid sequence comprising at least 95% identity with SEQ ID NO: 1, excluding SEQ ID NO: 3;

culturing the enterobacterial host cell under conditions effective to produce the protein; and

obtaining the protein from the enterobacterial host cell.

6 . The method of claim 5 , wherein the expression vector further comprises a nucleic acid sequence having at least 95% identity with SEQ ID NO: 2, excluding SEQ ID NO: 4.

7 . The method of claim 5 , wherein the enterobacteria comprises Escherichia Coli.

8 . The method of claim 5 , wherein the obtaining comprises lysing the transformed cell using a microfluidizer.

9 . The method of claim 8 , wherein the lysing produces a cell lysate, and the method further comprises:

(i) clarifying the cell lysate; and

(ii) contacting the clarified lysate with a synthetic adsorbent of crystalline calcium silicate hydrate.

10 . The method of claim 8 , wherein the lysing produces a cell lysate, and the method further comprises:

(i) clarifying the cell lysate; and

(ii) titrating the clarified lysate with acid to a pH of about 3.5 or less.

11 . The method of claim 8 , wherein the lysing produces a cell lysate, and the method further comprises:

(i) clarifying the cell lysate;

(ii) titrating the clarified lysate with acid to a pH of about 2 or less; and

(iii) adding lipopolysaccharide.

12 . The method of claim 11 , further comprising, prior to adding the lipopolysaccharide:

(i) neutralizing the acidified lysate;

(ii) filtering the neutralized lysate;

(iii) subjecting the filtered lysate to chromatography to yield the protein;

(iv) filtering the protein;

(v) dialyzing the filtered protein; and

(vi) filtering the dialyzed protein.

13 . The method of claim 12 , further comprising filtering the dialyzed, filtered protein at least a second time.

14 . The method of claim 8 , wherein the lysing produces a cell lysate, and the method further comprises:

(i) clarifying the cell lysate;

(ii) titrating the clarified lysate with acid to a pH of about 3.5 to produce a first acidified lysate;

(iii) clarifying the first acidified lysate; and

(iv) acidifying the clarified, first acidified lysate to a pH of less than about 2 to produce a second acidified lysate.

15 . The method of claim 14 , further comprising:

(i) clarifying the second acidified lysate;

(ii) filtering the second acidified lysate;

(iii) neutralizing the filtered, second acidified lysate;

(iv) filtering the neutralized lysate;

(v) subjecting the filtered, neutralized lysate to chromatography to yield the protein;

(vi) filtering the protein;

(vii) dialyzing the filtered protein; and

(viii) filtering the dialyzed protein.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 28, 2024
From: CONCHA, LUIS; FARRIS, CARLY; HOLGUIN, BRET; MA, YIHUA
To: AMPRION, INC.
Reel/Frame 066939/0825 →