Abstract: The instant invention relates to low acidic species (AR) compositions comprising a protein, e.g., an antibody, or antigen-binding portion thereof, and methods, e.g., cell culture and/or protein purification methods, for producing such low AR compositions. Methods for using such compositions to treat a disorder, e.g., a disorder in which TNF? is detrimental, are also provided.

Abstract: The instant invention relates to the field of protein production and purification, and in particular to compositions and processes for controlling the amount of charge variants, aggregates, and fragments of a protein of interest, as well as host cell proteins, present in purified preparations by applying particular chromatography conditions during such protein purification.

Abstract: The instant invention relates to low acidic species (AR) compositions comprising a protein, e.g., an antibody, or antigen-binding portion thereof, and methods, e.g., cell culture and/or protein purification methods, for producing such low AR compositions. Methods for using such compositions to treat a disorder, e.g., a disorder in which TNF? is detrimental, are also provided.

Abstract: The instant invention relates to low acidic species (AR) compositions comprising a protein, e.g., an antibody, or antigen-binding portion thereof, and methods, e.g., cell culture and/or protein purification methods, for producing such low AR compositions. Methods for using such compositions to treat a disorder, e.g., a disorder in which TNF? is detrimental, are also provided.

Abstract: The instant invention relates to low acidic species (AR) compositions comprising a protein, e.g., an antibody, or antigen-binding portion thereof, and methods, e.g., cell culture and/or protein purification methods, for producing such low AR compositions. Methods for using such compositions to treat a disorder, e.g., a disorder in which TNF? is detrimental, are also provided.

Abstract: The present invention relates to compositions and highly sensitive methods for the detection of biotechnology product residual when monitoring product carry over and/or for cleaning verification in the manufacture of biotechnology products. In particular, the present invention is directed to immunoassays wherein one or more capture antibodies, or antigen binding fragments thereof, are used to detect residuals associated with the production of biotechnology products.

Abstract: The present invention is directed to methods for purifying a protein of interest, e.g., an antibody, from a sample comprising the protein of interest and at least one impurity, e.g., an aggregate, by employing a hydrophobic interaction chromatography (HIC) method that allows for binding of both the protein of interest and the at least one impurity under strong binding conditions. The present invention is based, at least in part, on the finding that both flow through and bind-elute techniques can be combined to achieve greater purification and recovery of a protein of interest, e.g., an antibody, under isocratic wash conditions and strong binding conditions.

Abstract: The instant invention relates to the field of protein production and purification, and in particular to compositions and processes for controlling the amount of charge variants, aggregates, and fragments of a protein of interest, as well as host cell proteins, present in purified preparations by applying particular chromatography conditions during such protein purification.

Abstract: Disclosed herein is an integrated approach to purification process development and execution, including processes comprising particular capture and fine purification steps; processes that employ of a minimal number of buffer systems, and processes that make use of minimally-corrosive buffer systems, as well as combinations thereof.

Abstract: The present invention relates to compositions and highly sensitive methods for the detection of biotechnology product residual when monitoring product carry over and/or for cleaning verification in the manufacture of biotechnology products. In particular, the present invention is directed to immunoassays wherein one or more capture antibodies, or antigen binding fragments thereof, are used to detect residuals associated with the production of biotechnology products.

Abstract: A method of characterizing a multi-component mixture for use in a bioprocess operation that includes providing a multi-component mixture standard with pre-determined amounts of known components; performing a Raman Spectroscopy analysis on the multi-component mixture standard; providing a multi-component test mixture from the bioprocess operation; performing a Raman Spectroscopy analysis on the multi-component test mixture; and comparing the analysis of the multi-component mixture standard and the multi-component test mixture to characterize the multi-component test mixture. In one embodiment, the multi-component mixture standard and the multi-component test mixture both comprise one or more of, at least two, at least three of, or each of, a polysaccharide (e.g. sucrose or mannitol), an amino acid (e.g., L-arginine, L-histidine or L-ornithine), a surfactant (e.g. polysorbate 80) and a pH buffer (e.g., a citrate formulation).

Abstract: The present invention provides methods for the purification of plasmid DNA that includes removal of host cell impurities, such as endotoxins, RNA, proteins, and chromosomal DNA, from an aqueous solution containing plasmid DNA and methods for separation and purification of supercoiled plasmid DNA from an aqueous solution containing a mixture of supercoiled and nicked or relaxed plasmid DNA using hydrophobic interaction chromatography supports.