Jochen G. Salfeld - North Grafton MA, US Michael Roguska - Ashland MA, US Michael Paskind - Sterling MA, US Subhashis Banerjee - Hamden CT, US Daniel Edward Tracey - Harvard MA, US Michael White - Framingham MA, US Zehra Kaymakcalan - Westborough MA, US Boris Labkovsky - Marlborough MA, US Paul Sakorafas - Newton Highlands MA, US Geertruida M. Veldman - Sudbury MA, US Amy Venturini - Lexington MA, US Angela Widom - Acton MA, US Stuart Friedrich - Cary NC, US Nicholas W. Warne - Andover MA, US Angela Kantor - Pepperell MA, US John Gawain Elvin - Meldreth, GB Alexander Robert Duncan - Carton, GB Elaine Joy Derbyshire - Crowthorne, GB Sara Carmen - Cambridge, GB Stephen Smith - Ely, GB Thor Las Holtet - Rønde, DK Sarah Leila Du Fou - Hitchen, GB
Human antibodies, preferably recombinant human antibodies, that specifically bind to human interleukin-12 (hIL-12 ) are disclosed. Preferred antibodies have high affinity for hIL-12 and neutralize hIL-12 activity in vitro and in vivo. An antibody of the invention can be a full-length antibody or an antigen-binding portion thereof. The antibodies, or antibody portions, of the invention are useful for detecting hIL-12 and for inhibiting hIL-12 activity, e. g. , in a human subject suffering from a disorder in which hIL-12 activity is detrimental. Nucleic acids, vectors and host cells for expressing the recombinant human antibodies of the invention, and methods of synthesizing the recombinant human antibodies, are also encompassed by the invention.
Nicholas W. Warne - Andover MA, US Donna Luisi - Andover MA, US Angela Kantor - Pepperell MA, US
Assignee:
Janssen Alzheimer Immunotherapy - Little Island Wyeth LLC - Madison NJ
International Classification:
A61K 39/395
US Classification:
4241331
Abstract:
The present invention provides formulations for maintaining the stability of Aβ binding polypeptides, for example, Aβ antibodies. Exemplary formulations include a tonicity agent such as mannitol and a buffering agent or amino acid such as histidine. Other exemplary formulations include an antioxidant in a sufficient amount as to inhibit by-product formation, for example, the formation of high molecular weight polypeptide aggregates, low molecular weight polypeptide degradation fragments, and mixtures thereof. The formulations of the invention optionally comprise a tonicity agent, such as mannitol, and a buffering agent or amino acid such as histidine. The formulations are suitable for several different routes of administration.
Li Li - Sudbury MA, US Angela Kantor - Pepperell MA, US Shannon MacMillan - Hollis NH, US
Assignee:
Wyeth - Madison NJ
International Classification:
A61K 39/395
US Classification:
424133100
Abstract:
Formulations are described that are suitable for storage of proteins, such as antibodies, over a relatively broad range of protein concentrations, pH, and buffer types. Also described are methods of storing a protein and methods of identifying a suitable formulation for storage of a specific protein. In general, a formulation contains low to no surfactant, no to relatively low salt concentrations, and requires a relatively low buffer concentration.
Nicholas Warne - Andover MA, US Donna Luisi - North Andover MA, US Angela Kantor - Pepperell MA, US
International Classification:
A61K 39/395 A61K 31/4172 A61K 31/198
US Classification:
424133100, 514400000, 514562000
Abstract:
The present invention provides formulations for maintaining the stability of Aβ binding polypeptides, for example, Aβ antibodies. Exemplary formulations include a tonicity agent such as mannitol and a buffering agent or amino acid such as histidine. Other exemplary formulations include an antioxidant in a sufficient amount as to inhibit by-product formation, for example, the formation of high molecular weight polypeptide aggregates, low molecular weight polypeptide degradation fragments, and mixtures thereof. The formulations of the invention optionally comprise a tonicity agent, such as mannitol, and a buffering agent or amino acid such as histidine. The formulations are suitable for several different routes of administration.
Donna Luisi - North Andover MA, US Nicholas Warne - Andover MA, US Angela Kantor - Pepperell MA, US
International Classification:
A61K 39/395 A61K 31/4172 A61K 31/198
US Classification:
424133100, 514400000, 514562000
Abstract:
The present invention provides formulations for maintaining the stability of polypeptides, in particular, therapeutic antigen-binding polypeptides such as antibodies and the like, for example, anti-Aβ antibodies. The formulations generally include an antioxidant in a sufficient amount as to inhibit by-product formation, for example, the formation of high molecular weight polypeptide aggregates, low molecular weight polypeptide degradation fragments, and mixtures thereof. The formulations of the invention optionally comprise a tonicity agent, such as mannitol, and a buffering agent or amino acid such as histidine, and thus, the formulations are suitable for several different routes of administration.
Prediction Of Relative Polypeptide Solubility By Polyethylene Glycol Precipitation
Li Li - Sudbury MA, US Angela Kantor - Pepperell MA, US Nicholas Warne - Andover MA, US
Assignee:
Wyeth - Madison NJ
International Classification:
G01N 33/00
US Classification:
436086000
Abstract:
A method is described for predicting the relative solubility of a polypeptide using polyethylene glycol (PEG) based volume exclusion precipitation. Different polypeptides can be tested for their solubilities relative to each other or relative to a reference. A single polypeptide can be tested for its relative solubility under different experimental conditions. The solubility determinations can be made by comparison based on graphs plotting the log solubility of the polypeptide against a range of PEG concentrations. Additionally, a method is provided for the high throughput visual or automated screening of multiple polypeptides for relative solubility differences, in a method that can omit the step of measuring the actual solubility or actual amount of precipitation of each sample at each PEG concentration.
Nicholas Warne - Andover MA, US Angela Kantor - Pepperell MA, US Thomas Crowley - Wilmington MA, US Erin Soley - Lowell MA, US Li Li - Sudbury MA, US Nicholas Luksha - Malden MA, US Edie Neidhardt - Boxford MA, US
Assignee:
Wyeth - Madison NJ
International Classification:
C07K 14/755 C07K 1/14 C07K 14/00
US Classification:
530383000, 530350000, 530412000
Abstract:
Methods of reducing aggregation of a protein or proteins in a formulation, and protein formulations having reduced aggregation properties are provided. The methods and formulations described herein maintain the biological activity of a protein and increase the shelf life of protein formulations.
Methods For Reducing Or Preventing Liquid-Liquid Phase Separation In High Concentration Protein Solutions
Li Li - Sudbury MA, US Angela Kantor - Pepperell MA, US Nicholas Warne - Andover MA, US
Assignee:
Wyeth - Madison NJ
International Classification:
G01N 33/536 C07K 1/00 G01N 33/00
US Classification:
435004000, 436536000, 530412000
Abstract:
Methods of formulating proteins at high concentrations in protein solutions, wherein the protein solutions lack or have reduced liquid-liquid phase separation are described. Such protein solutions are substantially clear and substantially homogenous. Additionally, methods of concentrating and purifying proteins using liquid-liquid phase separation are provided.