Small-scale mixer

Abstract

Systems and methods for manufacturing small-scale mixers are provided. In some implementations, the methods include obtaining dimensions of the large-scale mixer. The methods also include determining a first dimension of the small-scale mixer based on the respective dimensions of the large-scale mixer. The methods further include determining a second dimension of the small-scale mixer that is independent of the dimensions of the large-scale mixer. Additionally, the methods include generating the small-scale mixer using the first dimension and the second dimension using a three-dimensional printer.

Claims

1. A method for manufacturing a small-scale mixer for mixing biopharmaceutical proteins into aqueous formulations, To obtain multiple dimensions of a large-scale mixer, including one or more of the following: impeller clearance from the bottom of the mixer (C), impeller diameter (D), liquid level (H), rotational speed (N), tank diameter (T), blade width (W), blade height (BH), and baffle width (WB), The first set of dimensions of the small-scale mixer is determined by applying scaling factors to the set of dimensions of the large-scale mixer. Using computational fluid dynamics techniques, the physical forces acting on the impeller and the shear forces exerted by the impeller on the biopharmaceutical protein in the aqueous formulation are simulated over various rotational speeds, fluid densities, and temperatures generated by the small-scale mixer, thereby determining a second set of dimensions for the small-scale mixer calculated to prevent degradation of the biopharmaceutical protein in the aqueous formulation. To manufacture the small-scale mixer having a combination of the first and second sets of dimensions of the small-scale mixer using a three-dimensional printer. The method, including the method described above.

2. The method according to claim 1, further comprising smoothing the surface of the small-scale mixer.

3. The method according to claim 1, further comprising smoothing the surface of the small-scale mixer, wherein the smoothing includes mechanically abrading the surface of the small-scale mixer.

4. The method according to claim 1, further comprising smoothing the surface of the small-scale mixer, wherein the smoothing comprises chemically polishing the surface of the small-scale mixer using a volatile solvent.

5. The method according to claim 1, wherein the production of the small-scale mixer comprises three-dimensional printing using one of the following materials: PC (polycarbonate), ABS (acrylonitrile butadiene styrene), PLA (polylactic acid), PET (polyethylene terephthalate), nylon, metal, and glass-filled PET.

6. The method according to claim 1, further comprising smoothing the surface of the small-scale mixer, wherein the smoothing comprises chemically polishing the surface of the small-scale mixer using acetone or dichloromethane.

7. The method according to claim 1, wherein the biopharmaceutical protein comprises a shear-sensitive molecule.

8. The method according to claim 1, wherein the biopharmaceutical protein comprises an antibody.

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