Abstract: What is described herein relates to a method and a device for dissociating cell agglomerations in the range of between >30 ?m to 300 ?m after harvest into single cells or cell oligomers in the range of 8-30 ?m comprising the steps of providing cell agglomerations in the range of between >30 ?m to 300 ?m passing said cell agglomerations in the range of between >30 ?m to 300 ?m through a recirculation loop bringing said cell agglomerations in the range of between >30 ?m to 300 ?m into contact with a shear component exerting a maximal shear in the range of between 2 Pa and 500 Pa thereby dissociating the cell agglomerations in the range of between >30 ?m to 300 ?m into single cells or cell oligomers in the range of 8-30 ?m.

Abstract: Described herein is a method and a system for automated simultaneous control of at least two process characteristics of a continuous production process with at least one fluid stream, at least two unit operations, at least one process control system and at least one conditioning volume.

Abstract: What is disclosed herein describes a system and a method for influencing a sequential chromatography.

Abstract: Herein is described a pressure resistant shell for stabilizing a welding seam of a weldable tubing as well as a method of using it.

Abstract: Described herein is a method for transferring of batch production process for a monoclonal antibody to a continuous production process for the same monoclonal antibody.

Abstract: The invention relates to a modular production plant for continuous production and/or preparation of biopharmaceutical products, a computer-implemented method for process control of the modular plant for production of biopharmaceutical and biological macromolecular products, in particular of proteins, e.g. monoclonal antibodies, vaccines, nucleic acids such as DNA, RNA and plasmids and derivatives thereof.

Abstract: Disclosed herein is a method for validation of continuous viral clearance comprising the steps of providing a probe to be validated, spiking the probe in a valid manner, performing viral clearance, sampling the spiked probe and analyzing the sample of the spiked probe of step d).

Abstract: Disclosed herein is a unit for ultrafiltration and purification (1) of a product stream (3) containing a biological macromolecular product as well as a substance to be separated from the product stream, comprising at least one capillary ultrafiltration module (2), characterized in that at least one pump (4) conveys the product stream into the capillaries of the at least one capillary ultrafiltration module, at least one positive displacement pump (5) conveys the product stream from the capillaries and at least one further pump (6) passes a washing fluid (9) over the outside of the capillaries, the unit includes no measure for circulating the product stream and the washing fluid into the ultrafiltration module, as well as at least one guard filter (8), through which all fluid leaving the at least one capillary ultrafiltration module in the direction of the product stream is passed.

Abstract: The invention provides a method for the continuous, microbe-reduced production and/or processing of a biopharmaceutical, biological macromolecular product from a heterogeneous cell culture-fluid mixture, comprising the steps of: (a) providing a particle-free fluid from a heterogeneous cell culture-fluid mixture containing the product, in the form of a product stream, (b) at least one filtration, providing a filtrate, (c) at least two chromatography steps for purifying the product, (d) at least one virus depletion, (e) at least one ultrafiltration and/or at least one diafiltration of the product stream of steps (b), (c) and/or (d), characterized in that the at least two chromatography steps from (c) comprise a purification via at least two chromatography columns and/or membrane adsorbers in each case and that the process is carried out in a closed and modular manner The invention further provides a corresponding modular system for carrying out said method.

Abstract: What is described herein relates to the use of a dense membrane module as pathogen barrier as well as the use of at least one dense membrane module and/or at least one nanoporous membrane module in a method for the continuous, processing of a healthcare product, a method for the continuous, pathogen-reduced, modular processing of a healthcare product, wherein at least one dense membrane module and/or at least one nanoporous membrane module is employed for degassing and/or debubbling a fluid stream, wherein the fluid stream is passed over the membrane module characterized in that the fluid stream is passed from top to bottom over the membrane module and a unit operation for the continuous, pathogen-reduced, modular processing of a healthcare product comprising at least one dense membrane module and/or at least one nanoporous membrane module.

Abstract: Disclosed herein is a method for monitoring the concentration of at least one kind of contaminant in a fluid stream, comprising the steps of providing at least two unit operations, providing a fluid stream, which passes said at least two unit operations in a flow path, sampling the fluid stream in a predetermined valid manner, determining the contaminant concentration in the sample in order to monitor the contaminant concentration in the fluid stream, wherein the method is carried out under continuous, closed and pathogen-reduced conditions.

Abstract: Disclosed herein is a device comprising at least one pathogen-reduced collection container, which is in fluid connection with at least one non-sterile waste disposal site (16) via at least one distributor comprising at least three attachment points for tubes and a method for using the this device.

Abstract: Disclosed herein is a method for validation of continuous viral clearance comprising the steps of providing a probe to be validated, spiking the probe in a valid manner, performing viral clearance, sampling the spiked probe and analyzing the sample of the spiked probe of step d).

Abstract: The invention provides a method for continuous virus inactivation. The product stream is segmented by introducing a separating medium which is immiscible with the product stream and the segmented product stream is transported into a reactor 1 as detention segment under virus-inactivating conditions for the required detention time.

Abstract: The invention relates to an ultrafiltration unit for continuous buffer or medium exchange, a method for continuous buffer or medium exchange in the ultrafiltration unit, and a plant in particular for (semi)continuous production of biopharmaceutical and biological macromolecular products in particular, such as proteins, e.g. monoclonal antibodies and vaccines, comprising the ultrafiltration unit according to the invention.

Abstract: The invention provides a method for continuous virus inactivation. The product stream is segmented by introducing a separating medium which is immiscible with the product stream and the segmented product stream is transported into a reactor 1 as detention segment under virus-inactivating conditions for the required detention time.

Abstract: The invention provides a method for the continuous, microbe-reduced production and/or processing of a biopharmaceutical, biological macromolecular product from a heterogeneous cell culture-fluid mixture, comprising the steps of: (a) providing a particle-free fluid from a heterogeneous cell culture-fluid mixture containing the product, in the form of a product stream, (b) at least one filtration, providing a filtrate, (c) at least two chromatography steps for purifying the product, (d) at least one virus depletion, (e) at least one ultrafiltration and/or at least one diafiltration of the product stream of steps (b), (c) and/or (d), characterized in that the at least two chromatography steps from (c) comprise a purification via at least two chromatography columns and/or membrane adsorbers in each case and that the process is carried out in a closed and modular manner The invention further provides a corresponding modular system for carrying out said method.

Abstract: The invention relates to a modular production plant for continuous production and/or preparation of biopharmaceutical products, a computer-implemented method for process control of the modular plant for production of biopharmaceutical and biological macromolecular products, in particular of proteins, e.g. monoclonal antibodies, vaccines, nucleic acids such as DNA, RNA and plasmids and derivatives thereof.

Abstract: The invention provides a method for the continuous elution of a biopharmaceutical, biological, macromolecular product from more than one chromatography column, comprising the steps of: (a) providing a product stream via an inlet, (b) simultaneously loading n front chromatography columns with the product stream in a loading zone with a loading time tB, an outlet stream of the n front chromatography columns being simultaneously distributed to at least n-1 recovery chromatography columns in a recovery zone, where n is between 1 and 5, and where the n front chromatography columns at a given time point have a varying loading time tB between 0 and L1, between L1 and L2, and up to between Ln-1 and Ln, where each front chromatography column has a total loading time of Ln, characterized in that, periodically after a constant switch time tS of Ln-1, the front chromatography column n comes out of the loading zone and a recovery chromatography column from the recovery zone enters the loading zone, (c) washing the product

Abstract: The invention relates to an ultrafiltration unit for continuous buffer or medium exchange, a method for continuous buffer or medium exchange in the ultrafiltration unit, and a plant in particular for (semi)continuous production of biopharmaceutical and biological macromolecular products in particular, such as proteins, e.g. monoclonal antibodies and vaccines, comprising the ultrafiltration unit according to the invention.