Michael J Griffith

US Patent:

20100081187, Apr 1, 2010

Filed:

Apr 28, 2008

Appl. No.:

12/597456

Inventors:

Michael J. Griffith - San Juan Capistrano CA, US
William N. Drohan - Gemantown MD, US
Marian J. Drohan - Germntown MD, US

International Classification:

C12N 9/48
C07K 1/14
C07K 1/16
C07K 14/00
C07K 9/00
C07K 14/745

US Classification:

435212, 530412, 530417, 530350, 530395, 530384

Abstract:

Methods of isolating highly sialylated recombinant vitamin K dependent proteins, particularly Factor IX, by chromatographic methods are described. The highly sialylated recombinant proteins are characterized. The improved Factor IX has at least 62% N-glycosylation with 3 or 4 sialic acid residues and improved bioavailability and pharmokinetic properties.

US Patent:

20100316625, Dec 16, 2010

Filed:

Dec 16, 2008

Appl. No.:

12/744017

Inventors:

Samia Mankarious - Costa Mesa CA, US
Michael J. Griffith - San Juan Capistrano CA, US

Assignee:

Inspiration Biopharmaceuticals, Inc. - Laguna Niguel

International Classification:

A61K 38/48
A61P 7/04

US Classification:

424 9464

Abstract:

Methods of preparing lyophilized preparations of Factor IX which preserve more than 90% of the calcium binding property of Factor IX are disclosed. Factor IX formulated with trehalose shows a superior stability profile after 12 weeks storage at 25 C./60% relative humidity (RH) and 40 C./75% RH relative to Factor IX formulated without trehalose. The data suggest that the inclusion of trehalose in the formulation could allow for temperature excursions or even long-term room temperature storage of a Factor IX lyophilized product. The formulations tested contained 10 mM histidine pH 6.8, 3% mannitol, 66 mM sodium chloride, 0.0075% Polysorbate 80, with and without 1% trehalose. Upon storage at 40 C./75% RH or 25 C./60% RH over 12 weeks the trehalose-containing formulation was comparable to product stored at 2-8 C. while the formulation without trehalose was found to undergo significant aggregation and loss of activity. The two formulations demonstrated comparable stability over 26 weeks of real time storage at −20 C. and 2-8 C.

US Patent:

20130266982, Oct 10, 2013

Filed:

Nov 19, 2012

Appl. No.:

13/681021

Inventors:

- Winnipeg, CA
Michael J. Griffith - San Juan Capistrano CA, US
John R. Taylor - Winnipeg, CA
Darrell W. Stafford - Winnipeg, CA

International Classification:

C12P 21/00
C12N 9/64

US Classification:

435 691, 435219

Abstract:

The invention relates to commercially viable methods for producing biologically active vitamin K dependent proteins, particularly Factor IX. Factor IX is produced at a level of at least about 15 mg/L and is at least 25% biologically active. The method relies upon co-expression of one or more of paired basic amino acid converting enzyme (PACE), vitamin K dependent epoxide reductase (VKOR) and vitamin K dependent γ-glutamyl carboxylase (VKGC) at a preferred ratio so that the vitamin K dependent protein is efficiently produced and processed by a recombinant cell.

US Patent:

54709547, Nov 28, 1995

Filed:

Oct 21, 1993

Appl. No.:

8/140695

Inventors:

Gerard G. Neslund - Diamond Bar CA
Michael J. Griffith - Claremont CA

Assignee:

Baxter International Inc. - Deerfield IL

International Classification:

A61K 3516
C07K 118
C07K 122
C07K 14755

US Classification:

530383

Abstract:

A process for purifying Factor VIII:C comprising contacting an immobilized antibody specifically binding a Factor VIII:C with Factor VIII: C, desorbing Factor VIII:C from the antibody which had adsorbed it, eluting Factor VIII:C from the presence of the antibody, passing the eluted Factor VIII:C through an affinity region capable of binding the Factor VIII:C, binding the Factor VIII:C in the affinity region and passing contaminants through said region, and eluting the purified Factor VIII:C.

US Patent:

50931172, Mar 3, 1992

Filed:

Jan 24, 1989

Appl. No.:

7/300836

Inventors:

Joyce E. Lawrence - Claremont CA
Michael J. Griffith - Claremont CA
Melaine Alpern - Long Beach CA

Assignee:

Baxter International Inc. - Deerfield IL

International Classification:

A61K 3704
A61K 3700

US Classification:

424 858

Abstract:

Pharmaceutical compositions useful for the treatment or prophylaxis of Gram-negative bacteremia or septic shock contain a bactericidal effective amount of polyclonal immunoglobulins against Gram-negative bacteria and a blood clot-dissolving effective amount of protein C. The compositions may further contain one or more protein C cofactors and monoclonal antibodies against Gram-negative bacterial endotoxins. A method for the treatment or prophylaxis of Gram-negative bacteremia or septic shock comprises administering, either together or separately, a bactericidal effective amount of polyclonal immunoglobulins against Gram-negative bacteria and a blood clot-dissolving effective amount of protein C. The method may optionally include administering one or more protein C cofactors and monoclonal antibodies against Gram-negative bacterial endotoxins.

US Patent:

53546822, Oct 11, 1994

Filed:

Feb 24, 1993

Appl. No.:

8/023143

Inventors:

Henry S. Kingdon - Pasadena CA
Michael J. Griffith - Walnut CA
Joyce Lawrence - Claremont CA
Roger L. Lundblad - Chapel Hill NC

Assignee:

Baxter International Inc. - Deerfield IL

International Classification:

C12N 974
A61K 3514
A61K 37475

US Classification:

435214

Abstract:

A purified therapeutic grade thrombin is described which is essentially free of lipid envelope viruses, has a specific activity of about 2200 NIH units per milligram of protein to about 3200 NIH units per milligram of protein, is essentially homogeneous and may be produced on a commercial-scale. The thrombin is acceptable from human administration.

US Patent:

20190167797, Jun 6, 2019

Filed:

Jul 6, 2018

Appl. No.:

16/028736

Inventors:

- Seattle WA, US
Michael J. Griffith - San Juan Capistrano CA, US

International Classification:

A61K 47/36
A61K 9/19
A61K 47/18
A61K 38/48
A61K 9/00
A61K 47/26
A61K 47/02

Abstract:

Methods of preparing lyophilized preparations of Factor IX which preserve more than 90% of the calcium binding property of Factor IX are disclosed. Factor IX formulated with trehalose shows a superior stability profile after 12 weeks storage at 25 C./60% relative humidity (RH) and 40 C./75% RH relative to Factor IX formulated without trehalose. The data suggest that the inclusion of trehalose in the formulation could allow for temperature excursions or even long-term room temperature storage of a Factor IX lyophilized product. The formulations tested contained 10 mM histidine pH 6.8, 3% mannitol, 66 mM sodium chloride, 0.0075% Polysorbate 80, with and without 1% trehalose. Upon storage at 40 C./75% RH or 25 C./60% RH over 12 weeks the trehalose-containing formulation was comparable to product stored at 2-8 C. while the formulation without trehalose was found to undergo significant aggregation and loss of activity. The two formulations demonstrated comparable stability over 26 weeks of real time storage at −20 C. and 2-8 C.

US Patent:

20160287709, Oct 6, 2016

Filed:

Oct 9, 2015

Appl. No.:

14/879310

Inventors:

- Winnipeg, CA
Michael J. Griffith - San Juan Capistrano CA, US

International Classification:

A61K 47/36
A61K 38/48

Abstract:

Methods of preparing lyophilized preparations of Factor IX which preserve more than 90% of the calcium binding property of Factor IX are disclosed. Factor IX formulated with trehalose shows a superior stability profile after 12 weeks storage at 25 C./60% relative humidity (RH) and 40 C./75% RH relative to Factor IX formulated without trehalose. The data suggest that the inclusion of trehalose in the formulation could allow for temperature excursions or even long-term room temperature storage of a Factor IX lyophilized product. The formulations tested contained 10 mM histidine pH 6.8, 3% mannitol, 66 mM sodium chloride, 0.0075% Polysorbate 80, with and without 1% trehalose. Upon storage at 40 C./75% RH or 25 C./60% RH over 12 weeks the trehalose-containing formulation was comparable to product stored at 2-8 C. while the formulation without trehalose was found to undergo significant aggregation and loss of activity. The two formulations demonstrated comparable stability over 26 weeks of real time storage at −20 C. and 2-8 C.