Bayer Aktiengesellschaft

Martin Lobedann

Peter Schwan

Benjamin Maiser

Laura David

Volker Möhrle

Stephan Klutz

Safa Kutup Kurt

Nils Weber

Andrea Vester

Lisa Marie Waldschmidt

Sven-Oliver Borchert

Lutz-Peter Lenz

Kerstin Baumarth

Heiko Brandt

Jens Bernshausen

The invention provides a unit operation formed by a device and its use for continuous virus inactivation of a continuous flow of a process fluid. The unit operation formed by a device comprises a single inlet at one end and an outlet at the opposite end and at least one HFI, characterized in that the HFI further comprises at least one installation.

Unit operation and use thereof

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).

Validation of continuous viral clearance

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.

Modular system and process for the continuous, microbe-reduced production and/or processing of a product

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 reactoras detention segment under virus-inactivating conditions for the required detention time.

Method for continuous virus inactivation

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.

Ultrafiltration unit for continuous buffer or medium exchange from a protein solution

The invention provides an apparatus and a process for continuous virus inactivation. The apparatus for continuous virus inactivation in a product stream comprises a tube or hosehaving an inletand an outletin each case connected to a product flow linefor conveying the product stream, where the tube or the hoseis curved and/or helically coiled with a number n of windings around a coil axis h and has one or more changes in direction and/or bendsin the coil axis h having an angle &#x3b1; of from 45&#xb0; to 180&#xb0; to alter the direction of action of the normals of the centrifugal force and the apparatus is characterized by a Dean number&#x3e;0 and a torsion parameter&#x3e;0.

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Kö'ln, Germany

Martin Lobedann