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US 2026/0053987 A1Published application
Method for dynamic filtration of a cross-linked hydrogel
AssigneeMERZ PHARMA GmbH & CO. KGaA
InventorsMichael PFEIL, Wolfgang KESSLER, Manuel CONRAD, Bjoern NIEMCZAK, Patrik VUKOVIC
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Abstract
The present invention relates to a method for dynamic filtration of a cross-linked biopolymer-based hydrogel to remove unwanted molecules from the gel. In particular, the invention relates to dynamic filtration of a hyaluronic acid hydrogel using a dynamic filtration construction with rotating and semipermeable filter discs.
Claims20
A method for dynamic filtration of a cross-linked biopolymer-based hydrogel comprising the following steps:
- a) transferring a cross-linked biopolymer-based hydrogel, wherein the biopolymer-based hydrogel is cross-linked by means of a chemical cross-linking agent bearing at least two groups that are capable of reacting with one or more functional groups of the biopolymer-based hydrogel, in a dynamic filtration device which is equipped with a process chamber and at least one rotating semipermeable filter disc and diafiltrating the gel comprising the steps of:
- i) concentrating the gel by applying a rotational speed of the at least one rotating semipermeable filter disc within a range of 20 1/min to 500 1/min and an overpressure within a range of 0.5 to 6 bar to a concentration in a range of 10 to 70 mg/g;
- or pumping the gel directly into the process chamber of the dynamic filtration device,
- wherein a first container containing the gel is connected to an inlet of the dynamic filtration device, and
- wherein step (i) further comprises applying pressure to the first container and opening a way from the first container to the inlet of the dynamic filtration device;
- and
- ii) conducting a diafiltration to reduce unwanted molecules selected from unreactive or unbound cross-linking agent molecules and degradation products thereof by applying a rotational speed of the at least one rotating semipermeable filter disc within a range of 20 1/min to 500 1/min and an overpressure within a range of 0.5 to 6 bar,
- wherein the diafiltration involves adding water or a new buffer to a retentate at the same rate as filtrate is being generated,
- wherein a second container containing the water or the new buffer is connected to the inlet of the dynamic filtration device, and
- wherein step (ii) further comprises applying pressure to the second container and opening a way from the second container to the inlet of the dynamic filtration device;
- and
- b) optionally adding a mixture comprising a non-cross-linked polymer and water to the gel.
9 more elements
Dependencies are inferred from the claim text.