Methods and systems for developing chromatography protocols

A method of generating a chromatography protocol for a target molecule, the method comprising:

• identifying a first chromatography parameter and a second chromatography parameter;
• identifying a first performance criterion and a second performance criterion;
• selecting first test values for the first chromatography parameter;
• selecting second test values for the second chromatography parameter;
• identifying a chromatography media;
• generating first performance criterion values, wherein each first performance criterion value corresponds to a combination of a first test value and a second test value;
• generating second performance criterion values, wherein each second performance criterion value corresponds to a combination of a first test value and a second test value;
• generating a first pool of multivariate models, wherein each multivariate model of the first pool of multivariate models relates the first and second chromatography parameters to the first performance criterion;
• generating a second pool of multivariate models, wherein each multivariate model of the second pool of multivariate models relates the first and second chromatography parameters to the second performance criterion;
• generating first projected performance criterion values using each multivariate model of the first pool of multivariate models, wherein each first projected performance criterion value corresponds to a combination of a first test value and a second test value;
• generating second projected performance criterion values using each multivariate model of the second pool of multivariate models, wherein each second projected performance criterion value corresponds to a combination of a first test value and a second test value;
• determining a coefficient of determination for a multivariate model in the first pool of multivariate models;
• and
• determining a coefficient of determination for a multivariate model in the second pool of multivariate models;
• wherein the target molecule is an antibody-drug conjugate.

A method of purifying a target molecule, the method comprising:

• introducing a load including a high molecular weight species concentration (% HMW) of approximately 3 percent to approximately 20 percent to a chromatography apparatus comprising sartobind phenyl chromatography media, wherein the load is introduced at a density of approximately 10 grams of load per liter of total volume of the chromatography apparatus to approximately 40 grams per liter, and wherein the load comprises the target molecule and approximately 5 mM to approximately 200 mM of citrate;
• and
• passing an eluate comprising the target molecule from the chromatography apparatus, wherein a yield of the target molecule in the eluate is at least approximately 70%, and wherein a difference of the % HMW of load and a % HMW of the eluate is at least approximately 2%;
• wherein the target molecule is an antibody-drug conjugate.