Alan K Hunter

US Patent:

20130029377, Jan 31, 2013

Filed:

Jul 25, 2012

Appl. No.:

13/557855

Inventors:

Maire H. CAPARON - Chesterfield MO, US
Kevin J. RUST - Manchester MO, US
Alan K. HUNTER - Damascus MD, US
Joseph K. McLAUGHLIN - Ballwin MO, US
Kristin E. THOMAS - Wildwood MO, US
John T. HERBERG - Portage MI, US
Robert E. SHELL - Charlotte NC, US
Paul B. LANTER - Edwardsville IL, US
Bruce F. BISHOP - Warrenton MO, US
Robert L. DUFIELD - Windham NH, US
Xing WANG - Wildwood MO, US
Sa V. HO - Boston MA, US

Assignee:

PFIZER INC. - Groton CT

International Classification:

C12N 1/21
C12P 21/00

US Classification:

435 691, 43525233

Abstract:

Apolipoprotein A-1 Milano (ApoA-1M), the protein component of a high-density lipoprotein (HDL) mimic with promising potential for reduction of atherosclerotic plaque, is produced on a large scale by expression in . Significant difficulty with clearance of host cell proteins (HCPs) was experienced in the original manufacturing process, despite lengthy purification. Analysis of purified protein solutions and intermediate process samples led to the identification of several major HCPs, and a bacterial protease causing the production of a truncated species of ApoA-1M co-purifying with the product. Deletions in these genes from the original host strain succeeded in substantially reducing the levels of HCPs without adversely affecting overall fermentation productivity, contributing to a much more efficient and robust new manufacturing process.

US Patent:

20210395370, Dec 23, 2021

Filed:

Sep 2, 2021

Appl. No.:

17/465092

Inventors:

- Cambridge, GB
William K. WANG - Gaithersburg MD, US
Ambarish SHAH - Gaithersburg MD, US
Hasige SATHISH - Gaithersburg MD, US
Alan HUNTER - Gaithersburg MD, US
Christopher THOMPSON - Gaithersburg MD, US

International Classification:

C07K 16/28
B01D 15/16
B01D 15/36
B01J 41/14
B01J 41/20
A61K 47/68
C07K 1/18
C07K 17/02
A61K 39/395
A61K 47/02

Abstract:

The present invention provides methods for isolating an active polypeptide or immunoconjugate by purification of a solution containing both the active polypeptide or immunoconjugate and an acidic variant thereof, such as a deamidated variant, using anion exchange chromatography. The present invention also provides compositions, formulations, and unit dosage forms comprising the purified polypeptide or immunoconjugate.

US Patent:

20200407423, Dec 31, 2020

Filed:

Jun 15, 2020

Appl. No.:

16/901812

Inventors:

- Gaithersburg MD, US
Mariko FONSECA - Gaithersburg MD, US
Christopher THOMPSON - Gaithersburg MD, US
Alan HUNTER - Gaithersburg MD, US
Xiangyang WANG - Gaithersburg MD, US
Liu TIE - Gaithersburg MD, US
Yiming LI - Gaithersburg MD, US

International Classification:

C07K 14/765
A61K 47/64
C07K 1/18
C07K 1/22
C07K 14/78

Abstract:

The present invention relates to a method of purifying albumin-fusion proteins to reduce the level of oxidation of susceptible amino acid residues. The method comprises an affinity matrix chromatography step and an anion exchange chromatography step. The purified albumin-fusion proteins have low levels of oxidation and retain their enhanced half-life in vivo and its bioactivity. In some embodiments, the albumin-fusion protein comprises a scaffold, such as human Tenascin C scaffold. Compositions comprising the albumin-fusion protein are further disclosed.

US Patent:

20200231680, Jul 23, 2020

Filed:

Feb 10, 2020

Appl. No.:

16/786634

Inventors:

- Cambridge, GB
William K. WANG - Gaithersburg MD, US
Ambarish SHAH - Gaithersburg MD, US
Hasige SATHISH - Gaithersburg MD, US
Alan HUNTER - Gaithersburg MD, US
Christopher THOMPSON - Gaithersburg MD, US

International Classification:

C07K 16/28
B01D 15/16
B01D 15/36
B01J 41/14
B01J 41/20
A61K 47/68
C07K 1/18
C07K 17/02
A61K 39/395
A61K 47/02

Abstract:

The present invention provides methods for isolating an active polypeptide or immunoconjugate by purification of a solution containing both the active polypeptide or immunoconjugate and an acidic variant thereof, such as a deamidated variant, using anion exchange chromatography. The present invention also provides compositions, formulations, and unit dosage forms comprising the purified polypeptide or immunoconjugate.

US Patent:

20180371094, Dec 27, 2018

Filed:

Sep 7, 2018

Appl. No.:

16/124441

Inventors:

- Gaithersburg MD, US
William K. WANG - Gaithersburg MD, US
Ambarish SHAH - Gaithersburg MD, US
Hasige SATHISH - Gaithersburg MD, US
Alan HUNTER - Gaithersburg MD, US
Christopher THOMPSON - Gaithersburg MD, US

International Classification:

C07K 16/28
A61K 47/68
B01D 15/16

Abstract:

The present invention provides methods for isolating an active polypeptide or immunoconjugate by purification of a solution containing both the active polypeptide or immunoconjugate and an acidic variant thereof, such as a deamidated variant, using anion exchange chromatography. The present invention also provides compositions, formulations, and unit dosage forms comprising the purified polypeptide or immunoconjugate.

US Patent:

20180105575, Apr 19, 2018

Filed:

Mar 11, 2016

Appl. No.:

15/557358

Inventors:

- Gaithersburg MD, US
Mariko FONSECA - Gaithersburg MD, US
Christopher THOMPSON - Gaithersburg MD, US
Alan HUNTER - Gaithersburg MD, US
Xiangyang WANG - Gaithersburg MD, US
Liu TIE - Gaithersburg MD, US
Yiming LI - Gaithersburg MD, US

International Classification:

C07K 14/765
C07K 1/18
C07K 1/22
C07K 14/78

Abstract:

The present invention relates to a method of purifying albumin-fusion proteins to reduce the level of oxidation of susceptible amino acid residues. The method comprises an affinity matrix chromatography step and an anion exchange chromatography step. The purified albumin-fusion proteins have low levels of oxidation and retain their enhanced half-life in vivo and its bioactivity. In some embodiments, the albumin-fusion protein comprises a scaffold, such as human Tenascin C scaffold. Compositions comprising the albumin-fusion protein are further disclosed.

US Patent:

20170145100, May 25, 2017

Filed:

Feb 3, 2017

Appl. No.:

15/423928

Inventors:

- Gaithersburg MD, US
William K. WANG - Gaithersburg MD, US
Ambarish SHAH - Gaithersburg MD, US
Hasige SATHISH - Gaithersburg MD, US
Alan HUNTER - Gaithersburg MD, US
Christopher THOMPSON - Gaithersburg MD, US

International Classification:

C07K 16/28
A61K 47/02
A61K 39/395

Abstract:

The present invention provides methods for isolating an active polypeptide or immunoconjugate by purification of a solution containing both the active polypeptide or immunoconjugate and an acidic variant thereof, such as a deamidated variant, using anion exchange chromatography. The present invention also provides compositions, formulations, and unit dosage forms comprising the purified polypeptide or immunoconjugate.