摘要:
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.
摘要:
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 hose 1 having an inlet 4 and an outlet 5 in each case connected to a product flow line 8 for conveying the product stream, where the tube or the hose 1 is 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 bends 2 in the coil axis h having an angle α of from 45° to 180° to alter the direction of action of the normals of the centrifugal force and the apparatus is characterized by a Dean number>0 and a torsion parameter>0.
摘要:
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.
摘要:
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).
摘要:
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.
摘要:
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.
摘要:
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.
摘要:
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.