Abstract:
The present invention relates to a batch crystallization method for crystallizing anti-human TNFalpha (hTNFalpha) antibody and antibody fragments which allows the production of said antibody on an industrial scale; a method of controlling the size of antibody crystals, for example, crystals of anti-hTNFalpha antibody fragments, compositions containing said crystals as well as methods of use of said crystals and compositions.
Abstract:
The invention provides an aqueous formulation comprising water and a protein, and methods of making the same. The aqueous formulation of the invention may be a high protein formulation and/or may have low levels of conductivity resulting from the low levels of ionic excipients. Also included in the invention are formulations comprising water and proteins having low osmolality.
Abstract:
The invention provides compositions and methods for inhibiting fractionation of immunoglobulins comprising a lambda light chain based on the observation that iron, in the presence of histidine, results in increased fragmentation of a recombinant fully human IgG molecule containing a lambda light chain due to cleavage in the hinge region. The invention further provides an aqueous pharmaceutical formulation comprising an antibody, or antigen-binding portion thereof, that binds the p40 subunit of IL-12/IL-23 and a buffer system comprising histidine, wherein the formulation has enhanced stability, including enhanced resistance to fragmentation.
Abstract:
The invention relates to batch crystallization methods for crystallizing an anti-hIL-12 antibody that allows the production of the antibody on an industrial scale, antibody crystals obtained according to the methods, compositions containing the crystals, and methods of using the crystals and the compositions.
Abstract:
585702 Disclosed herein are aqueous formulations comprising water and at least about 20 mg/mL of an antibody, or antigen-binding fragment thereof, wherein the antibody, or antigen-binding fragment thereof, has a hydrodynamic diameter (Dh) which is at least about 50% less than the Dh of the antibody or had a hydrodynamic diameters of less than about 4 nm, or antigen-binding fragment thereof, in a buffered solution at the same concentration, and the antibody, or antigen-binding fragment thereof, has a molecular weight (Mw) greater than about 47 kDa. Specifically, wherein the antibody, or antigenbinding fragment thereof, is selected from the group consisting of adalimumab, alemtuzumab, CEA-Scan Arcitumomab (fab fragment), cetuximab, trastuzumab, imciromab pentetate, capromab pendetide, infliximab, abciximab, rituximab, basiliximab, palivizumab, nofetumomab, omalizumab, daclizumab, ibritumomab tiuxetan, muromonab-CD3, edrecolomab, gemtuzumab ozogamicin, golimumab, certolizumab pegol, eculizumab, ustekinumab, panitumumab, tositumomab and I131 tositumomab, and bevacizumab.
Abstract:
La invención proporciona composiciones y métodos para inhibir el fraccionamiento de las inmunoglobulinas que comprenden una cadena ligera lambda basado en la observación que el hierro, en presencia de histidina, da lugar al fraccionamiento creciente de una molécula de lgG completamente humana recombinante que contiene una cadena ligera lambda debido a la segmentación en la región bisagra. La invención además proporciona una formulación farmacéutica acuosa que comprende un anticuerpo, o porción de unión a antígeno del mismo, que une la subunidad p40 de IL-12/IL-23 y un sistema amortiguador que comprende histidina, en donde la formulación tiene una estabilidad mejorada, que incluye resistencia mejorada a la fragmentación.
Abstract:
Composiciones y métodos para inhibir el fraccionamiento de inmunoglobulinas que comprenden una cadena liviana lambda, sobre la base de la observación de que el hierro, en presencia de histidina, resulta en la fragmentación incrementada de una molécula de IgG recombinante completamente humana que contiene una cadena liviana lambda, debido a un corte en la región bisagra. Formulación farmacéutica acuosa que comprende un anticuerpo, o una porción de unión al antígeno de éste, que se une a la subunidad p40 de IL-12/IL-23. Sistema amortiguador que comprende histidina, donde la formulación presenta una estabilidad mejorada, incluyendo una resistencia mejorada a la fragmentación.
Abstract:
Abstract The invention relates to batch crystallization methods for crystalizing an anti-hlL-12 antibody that allows the production of the antibody on an industrial scale, antibody crystals obtained according to the methods, compositions containing the crystals, and methods of using the crystals and the compositions.
Abstract:
Abstract Stable antibody compositions and methods for stabilizing same The invention provides compositions and methods for inhibiting fractionation of immunoglobulins comprising a lambda light chain based on the observation that iron, in the presence of histidine, results in increased fragmentation of a recombinant fully human IgG molecule containing a lambda light chain due to cleavage in the hinge region. The invention further provides an aqueous pharmaceutical formulation comprising an antibody, or antigen binding portion thereof, that binds the p40 subunit of IL-12/lL-23 and a buffer system comprising histidine, wherein the formulation has enhanced stability, including enhanced resistance to fragmentation.