阅读说明：本技术 色谱方法、测定在色谱方法中至少两种参数的相互依赖性的影响的方法及获得至少一种色谱方法参数的方法 (Chromatographic method, method for determining the effect of interdependence of at least two parameters in a chromatographic method and method for obtaining at least one chromatographic parameter ) 是由 简·施韦伦巴赫 沃克马尔·汤姆 多米尼克·斯坦 于 2020-05-08 设计创作，主要内容包括：本发明涉及色谱方法、测定在色谱方法中至少两种参数的相互依赖性的影响的方法及获得至少一种色谱方法参数的方法。(The present invention relates to a chromatography method, a method for determining the effect of interdependence of at least two parameters in a chromatography method and a method for obtaining at least one chromatography method parameter.)

1. A method for determining the effect of interdependence of at least two parameters in a chromatographic method, said method comprising the steps of:

(ia) selecting at least one compound;

(ib) selecting at least one stationary phase;

(ic) selecting at least one mobile phase;

(id) selecting at least one chromatography device having a chromatography bed comprising said at least one stationary phase and said at least one mobile phase;

(iia) determining the physical principles of the chromatographic method;

(iib) determining a relevant parameter from the physical principle;

(iiia) selecting said at least two parameters from said correlated parameters;

(iiib) determining the interdependence of said at least two parameters using said at least one chromatographic device and said at least one compound;

(iv) evaluating the relevant parameter using the determined interdependence of the at least two parameters; and

(v) assessing the effectiveness of the physical principle of the chromatographic method.

2. The method of claim 1, wherein the first and second light sources are selected from the group consisting of,

wherein the step of determining the interdependence of the at least two parameters (iiib) comprises one or more laboratory experiments.

3. The method according to claim 1 or 2,

wherein step (iia) is performed taking into account implementation of manufacturing, tolerances, side effects, deviations and/or error ranges.

4. The method of any one of claims 1 to 3,

wherein the at least two parameters are the internal velocity and diameter of the chromatography device:

wherein

v represents the velocity of the mobile phase in the chromatography bed,

the volumetric flow rate is expressed in terms of,

a represents the cross-sectional area of the chromatographic apparatus,

ε_brepresents the bulk porosity of the chromatographic bed, and

d represents the diameter of the chromatographic apparatus.

5. The method of any one of claims 1 to 4,

wherein said at least two parameters are the binding capacity q of said at least one stationary phase_iAnd ion capacity Λ:

wherein

c_eq,iRepresents the equilibrium concentration of component i in the mobile phase,

q_irepresents the equilibrium concentration of component i on the stationary phase,

k_eqwhich represents the equilibrium binding constant of the polymer,

a represents the total ion capacity,

v_irepresenting the characteristic charge of component i, and

σ_irepresents the masking factor for component i.

6. The method of any one of claims 1 to 5,

wherein the stationary phase is a chromatographic membrane or monolith.

7. The method of any one of claims 1 to 6,

wherein the at least one compound comprises a protein and/or a drug.

8.A method of obtaining at least one chromatography method parameter selected from the group consisting of a stationary phase, a mobile phase and a chromatography device, said method comprising the steps of:

(I) performing the method of any one of claims 1 to 7; and

(II) selecting at least one stationary phase, at least one mobile phase and/or at least one chromatographic device based on the results of step (I).

9. A chromatographic process comprising

A method as claimed in any one of claims 1 to 7 for determining the effect of interdependence of at least two parameters in a chromatographic method, and

(vi) performing chromatography.

10. A chromatographic process comprising

The method of obtaining at least one chromatography parameter of claim 9, and

(III) a step of performing chromatography based on the at least one chromatography parameter selected in step (II).