Hoffmann-La Roche Inc.

F. Hoffmann-La Roche Ag

Julien Boeuf

Joerg Luemkemann

Imke Sonja Ludwig

Tim Dreckmann

Vincent Keehnen

Natalie Rakel

Alexander Ulmer

A process of assembling a filling system for low volume filling of a liquid into a container is disclosed. The process includes obtaining plural liquid forwarding devices configured to provide the liquid from a reservoir to the container, and simulating operation of each of the liquid forwarding devices by numerically modelling flow patterns of the liquid when being forwarded by the liquid forwarding devices, and by determining a shear stress rate for each of the liquid forwarding devices based on the modelled flow patterns. The process further includes determining an appropriateness for each of the liquid forwarding devices by comparing operation parameters of the liquid forwarding of the liquid forwarding devices, wherein the operation parameters include the determined shear stress rates, selecting the liquid forwarding device having the highest determined appropriateness, and installing the selected liquid forwarding device into the filling system.

Low volume filling of a liquid into a container

An inventive drug product filling device for filling a liquid drug product into containers is disclosed. The drug filling device includes a drug product preparer configured for preparing the liquid drug product and a filling station configured for filling the liquid drug product into the containers. The filling station is fluidly coupled to the drug product preparer. A degasser is fluidly interposed between the drug product preparer and the filling station. The degasser has a membrane configured for at least partially separating off gas from the liquid drug product. Methods of (i) filling a liquid drug product into containers, (ii) increasing the accuracy of the filling weight of a liquid drug product in a container, (iii) increasing the stability oxygen-sensitive active pharmaceutical ingredient in a liquid drug product, and (iv) reducing polysorbate aggregate formation in a liquid drug product are also disclosed.

Method of filling degassed drug product into containers and drug product filling device

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Mannheim, Germany

Julien Boeuf