Boehringer Ingelheim Rcv Gmbh & Co. Kg

Boehringer Ingelheim Austria Gmbh

Takeda Pharmaceutical Company Limited

Roman Necina

Christian Fiedler

Alois A Jungbauer

Ernst Boehm

Michael Graninger

Robert Schlegl

Jochen Urthaler

Christine Machold

Christine Ascher

Helga Woehrer

Helga Zambiasi

Marián BENDÍK

A scalable process and device for producing a biomolecule, in particular pharmaceutical grade plasmid DNA. The process includes the steps of alkaline lysis and a neutralization. For separating the lysate and the precipitate, the mixture is allowed to gently flow downward through a clarification reactor that is partially filled, in its lower part, with retention material like glass beads, whereby the precipitate is retained on top of and within the retention. In a preferred embodiment of the lysis step, cell suspension and alkaline lysis solution flow through a lysis reactor that is filled with particulate material like glass beads. The process can be run continuously and fully automated.

Methods and devices for producing biomolecules

In a method for reconstituting a recombinant protein from a denatured state to its active form, a feed solution containing the recombinant protein in its denatured and/or in biologically inactive intermediate forms is subjected to a chromatographic separation process, in which the protein is reconstituted under conditions that promote refolding of the protein and the intermediate forms are separated from the refolded protein. The denatured form and/or the inactive intermediate forms of the protein are separated from the refolded protein in a continuous or quasi-continuous manner and optionally recycled to the feed solution.

Method for reconstituting a recombinant protein to its biologically active form

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Vienna, Austria

Roman Necina