Wendy B Sunderland

US Patent:

20200171133, Jun 4, 2020

Filed:

Oct 16, 2019

Appl. No.:

16/654521

Inventors:

- Cranbury NJ, US
Sergey Tesler - Monroe NJ, US
Wendy Sunderland - Doylestown PA, US
Enrique Diloné - Basking Ridge NJ, US
Russell Gotschall - Doylestown PA, US
Hung Do - New Hope PA, US

International Classification:

A61K 38/47
C12N 9/26
A61K 9/00
A61K 9/19
A61K 47/02
A61K 47/12
A61K 47/26

Abstract:

Provided are pharmaceutical formulations comprising a recombinant acid α-glucosidase, wherein the recombinant acid α-glucosidase is expressed in Chinese hamster ovary (CHO) cells and comprises an increased content of N-glycan units bearing one or two mannose-6-phosphate residues when compared to a content of N-glycan units bearing one or two mannose-6-phosphate residues of alglucosidase alfa; at least one buffer selected from the group consisting of a citrate, a phosphate and combinations thereof; and at least one excipient selected from the group consisting of mannitol, polysorbate 80, and combinations thereof, wherein the formulation has a pH of from about 5.0 to about 7.0. Also provided are methods of treating Pompe disease using these pharmaceutical formulations.

US Patent:

20170333534, Nov 23, 2017

Filed:

Mar 30, 2017

Appl. No.:

15/473999

Inventors:

- Cranbury NJ, US
Sergey Tesler - Monroe NJ, US
Wendy Sunderland - Doylestown PA, US
Enrique Diloné - Basking Ridge NJ, US

International Classification:

A61K 38/47
A61K 47/12
A61K 47/02
A61K 9/19
A61K 47/26
A61K 9/00

Abstract:

Provided are pharmaceutical formulations comprising a recombinant acid α-glucosidase, wherein the recombinant acid α-glucosidase is expressed in Chinese hamster ovary (CHO) cells and comprises an increased content of N-glycan units bearing one or two mannose-6-phosphate residues when compared to a content of N-glycan units bearing one or two mannose-6-phosphate residues of alglucosidase alfa; at least one buffer selected from the group consisting of a citrate, a phosphate and combinations thereof; and at least one excipient selected from the group consisting of mannitol, polysorbate 80, and combinations thereof, wherein the formulation has a pH of from about 5.0 to about 7.0. Also provided are methods of treating Pompe disease using these pharmaceutical formulations.