Herein is reported a method for determining the presence of antibody-Fab-FcRn interaction in an antibody-Fc-FcRn complex influencing the in vivo half-life comprising the steps of a) determining the retention time of the antibody on an FcRn affinity chromatography column with a positive linear pH gradient elution in the presence of a first sodium chloride concentration, and b) determining the retention time of the antibody on an FcRn affinity chromatography column with a positive linear pH gradient elution in the presence of a second sodium chloride concentration, whereby the presence of antibody-Fab-FcRn interaction in an antibody-Fc-FcRn complex influencing the in vivo half-life is determined if the retention time determined in step a) and the retention time determined in step b) are substantially different.

Provided is a chiller and system that may be utilized in a supercritical fluid chromatography method, wherein a non-polar solvent may replace a portion or all of a polar solvent for the purpose of separating or extracting desired sample molecules from a combined sample/solvent stream. The system may reduce the amount of polar solvent necessary for chromatographic separation and/or extraction of desired samples. The system may incorporate a supercritical fluid chiller, a supercritical fluid pressure-equalizing vessel and a supercritical fluid cyclonic separator. The supercritical fluid chiller allows for efficient and consistent pumping of liquid-phase gases employing off-the-shelf HPLC pumps. The pressure equalizing vessel allows the use of off-the-shelf HPLC column cartridges. The system may further incorporate the use of one or more disposable cartridges containing silica gel or other suitable medium. The system may also utilize an open loop cooling circuit using fluids with a positive Joule-Thomson coefficient.

Provided herein are methods of separating host cell lipases from a production protein in chromatographic processes and methods of improving polysorbate-80 stability in a production protein formulation by separating host cell lipases from the production protein using chromatographic processes. Also provided are pharmaceutical compositions comprising less than 1 ppm of a host cell lipase.

A column-conditioning enclosure includes a column chamber adapted to hold one or more chromatography separation columns. A duct system provides an airflow path around the column chamber such that the one or more chromatography separation columns held within the column chamber are isolated from the airflow path. An air mover disposed in the airflow path generates a flow of air within the duct system. A heat exchanger system disposed in the airflow path near the air to exchange heat with the air as the air flows past the heat exchanger system. The air circulates through the duct system around the column chamber, convectively exchanging heat with the column chamber to produce a thermally conditioned environment for the one or more chromatography separation columns held within the column chamber.

A column-conditioning enclosure includes a column chamber adapted to hold one or more chromatography separation columns. A duct system provides an airflow path around the column chamber such that the one or more chromatography separation columns held within the column chamber are isolated from the airflow path. An air mover disposed in the airflow path generates a flow of air within the duct system. A heat exchanger system disposed in the airflow path near the air to exchange heat with the air as the air flows past the heat exchanger system. The air circulates through the duct system around the column chamber, convectively exchanging heat with the column chamber to produce a thermally conditioned environment for the one or more chromatography separation columns held within the column chamber.

Provided herein are methods of producing an adeno-associated virus (AAV) product and methods of purifying adeno-associated virus. AAV is loaded onto an affinity resin, wash steps are undertaken at room temperature, and AAV is eluted from the affinity resin at a lower temperature. Various buffers are disclosed for use in the wash steps and elution.

The present invention provides a chromatographic separation process for recovering a polyunsaturated fatty acid (PUFA) product from a feed mixture, which process comprises passing the feed mixture through one or more chromatographic columns containing, as eluent, an aqueous organic solvent, wherein the temperature of at least one of the chromatographic columns through which the feed mixture is passed is greater than room temperature.

The present invention relates to a column chromatographic method of manufacturing non-carrier-added high-purity .sup.177Lu compounds for medicinal purposes. In the method in accordance with the invention a cation exchanger and a suitable chelating agent are used. With the method in accordance with the invention it is possible for the first time to provide non-carrier-added high-purity .sup.177Lu compounds in milligram amounts for pharmaceutical-medicinal purposes from .sup.176Yb compounds irradiated with thermal neutrons, the radionuclides .sup.177Lu and .sup.176Yb being present in an approximate mass ratio of 1:10.sup.2 to 1:10.sup.10 for purification.

Described is a method for vacuum degassing of a liquid such as a solvent for a liquid chromatography system. The method includes modulating application of a vacuum to a fluid channel of a degasser so that each volume of a liquid drawn from the degasser experiences a residence time that is equal to the residence times of the other volumes. The residence time is determined as a time that the volume resides in the fluid channel under application of the vacuum and to a magnitude of the applied vacuum. The method is advantageous for use with liquid chromatography systems where differences in the diffusion rates of solvents into the degasser vacuum can otherwise introduce error into the composition gradient of a mobile phase.

Described is a method for vacuum degassing of a liquid such as a solvent for a liquid chromatography system. The method includes modulating application of a vacuum to a fluid channel of a degasser so that each volume of a liquid drawn from the degasser experiences a residence time that is equal to the residence times of the other volumes. The residence time is determined as a time that the volume resides in the fluid channel under application of the vacuum and to a magnitude of the applied vacuum. The method is advantageous for use with liquid chromatography systems where differences in the diffusion rates of solvents into the degasser vacuum can otherwise introduce error into the composition gradient of a mobile phase.