Abstract: The present invention is directed to the development of continuous processing technology for the purification of biopharmaceuticals and biological products, such as monoclonal antibodies, protein therapeutics, and vaccines. Methods for continuous processing of a biological product in a feed stream toward formulation of a purified bulk product are described.

Abstract: The present invention is directed to the development of continuous processing technology for the purification of biopharmaceuticals and biological products, such as monoclonal antibodies, protein therapeutics, and vaccines. Methods for continuous processing of a biological product in a feed stream toward formulation of a purified bulk product are described.

Abstract: The invention feature methods for isolating a recombinant or transgenic polypeptide from egg albumen and a composition containing a transgeenic non-avian polypeptide.

Abstract: Binding molecules for detecting or isolating immunoglobulin Fc-region polypeptides are described, together with methods of use thereof. Preferred Fc-region binding polypeptides, recombinant bacteriophage expressing Fc-region binding polypeptides, and separation media exhibiting such polypeptides are particularly disclosed.

Abstract: The invention features compositions containing avian-derived transgenic non-avian antibodies and methods of recovering the compositions from transgenic avian eggs. Chromatographic techniques permit the purification of non-avain proteins produced in an avain tissue from contaminating avian tissue components for administration to humans.

Abstract: A chromatography cartridge assembly includes a cartridge and first and second end caps. A wall of the cartridge defines a chamber for containing chromatography media. The end caps define inlet and outlet passages, respectively, for flow of process fluid. The first end cap defines flow distributor passages for distributing process fluid across a cross-sectional area of the chamber, and the second end cap defines flow collector passages for collecting process fluid from across a cross-sectional area of the chamber. A clamp is circumferentially located about the cartridge wall for applying a radial load through the wall to the first end cap to fix the first end cap in a desired position.

Abstract: A chromatography cartridge assembly includes a cartridge with a flexible wall defining a chamber, and a porous, polymeric, hydrophilic, chromatography media contained within the chamber. The chromatography media has an operating pressure rating greater than 3 bars. The flexible wall forms a movable diaphragm for compressing the chromatography media. The chromatography cartridge assembly includes a flow distributor, flow collector, and sieves formed from a hydrophilic material. A compression module defines a pressure chamber for containing a pressurized fluid. The pressurized fluid acts to move the flexible wall of the cartridge assembly. The compression module has a pressure ratings greater than 3 bars.

Abstract: A liquid chromatography column protection system having a system pump, a bubble trap, and a column includes detectors for monitoring certain system conditions such as the presence of air or overpressurization and valves and controlling means for shutting down system operation when the conditions are detected.

Abstract: An automated bubble trap for a liquid chromatography system includes a bubble trap or reservoir with level sensing devices at spaced elevations so that the liquid chromatography system can be operated unattended on a day to day basis so long as the liquid level is maintained between the liquid sensing elevations. The automated bubble trap will correct a low level condition restoring the liquid level to proper limits. However if a dry line condition is inferred, then the automated bubble trap will shut down the system until the problem is resolved.

Abstract: Precise gradient control is accomplished using a high flow three-way valve, appropriate mixing, and precise metering control. Gradient elution profiles are generated for flow rates above 100 ml/min. Control involves precise selection of two solvents, and correction factors for valve lag times and pump/valve synchronizations. The gradient is controlled simultaneously with other non-timed operations through a single microprocessor controller.