In an LC system using an ODS column (15) and UV detector (17), a cannabis-derived sample is analyzed by gradient elution using a phosphoric acid aqueous solution and phosphoric-acid-containing methanol. A control unit (3) regulates the openings of solenoid valves in a mixer (12) so that the increase rate of the mixture ratio of the phosphoric-acid-containing methanol in a second part of the analysis period is higher than in a first part. By this operation, ten active ingredients (including Total THC, Total CBD and CBN) contained in cannabis can be satisfactorily separated within an analysis time which is equal to or even shorter than approximately 30 minutes. Each ingredient separated by the column (15) is detected by the UV detector (17). An active ingredient identification processor (22) identifies the ten active ingredients based on the retention times of the peaks on a chromatogram created from the detection signals.

A method for preparing an aqueous solution of a defined pH comprising an acid, a base and optionally one or more additives is provided. The method comprises the steps of: a) calculating the theoretical concentrations of acid and base for the solution to have the defined pH using the Henderson-Hasselbach equation in combination with the Debye Huckel theory for a range of different additive concentrations; b) preparing a sample of the buffer for the range of additive concentrations and measuring the actual pH for each additive concentration; c) calculating a value for delta pH, pH, being the difference between the theoretical pH and the actual pH, for each additive concentration; d) generating a mathematical model describing the relationship of pH with additive concentration; e) selecting the defined pH and additive concentrations; f) using the mathematical model generated in step d) to calculate pH for the defined pH and additive concentration; g) calculating a pH-corrected pH by summing the defined pH and delta pH; h) using the pH-corrected pH to calculate the concentrations of acid and base using the Henderson-Hasselbach equation in combination with the Debye Huckel theory; i) preparing the solution using the concentrations calculated in step h).

The present invention provides methods for increasing purity of an Fc-containing protein by removing protein aggregates during the Protein A chromatography step used during the purification of the Fc-containing protein.

Herein is reported the use of an immobilized non-covalent complex of a neonatal Fc receptor (FcRn) and beta-2-microglobulin (b2m) as affinity chromotography ligand in general and, for example, for the determination of the in vivo half-live of an antibody by determining the ratio of the retention times of the antibody and a reference antibody.

A method of preparing a liquid mixture for use in a liquid chromatography system is provided. The mixture comprises one or more acids, one or more bases, one or more solvents and water, and the method comprises the steps of: calculating pH and/or solvent concentration at a particular time t from a user-determined gradient function; and, based on the values obtained, calculating percent acid, percent base, percent solvent and percent water in the liquid mixture at time t. A liquid chromatography system incorporating such method is also provided.

Herein is reported the use of an immobilized non-covalent complex of a neonatal Fc receptor (FcRn) and beta-2-microglobulin (b2m) as affinity chromatography ligand in general and, for example, for the determination of the in vivo half-live of an antibody by determining the ratio of the retention times of the antibody and a reference antibody.

Methods are provided for enhancing reduction of virus and viral DNA levels in protein preparations.

An electrodialytic buffer generator is described. The buffer generator may include a central buffer-generating channel having an inlet and outlet, a second chamber, and a third chamber. The buffer-generating channel, the second chamber, and the third chamber may each include an electrode. The buffer generator may also include a first ion exchange barrier and a second ion exchange barrier. The first ion exchange barrier can be disposed between the second chamber and the buffer-generating channel. The second ion exchange barrier can be disposed between the third chamber and the buffer-generating channel.

Buffer generators are described based on electrodialytic devices. The methods of using these devices can generate buffers for diverse applications, including separations, e.g., HPLC and ion chromatography. Also provided are chromatographic devices including the buffer generators, generally located upstream from a chromatography column, sample injector valve or both.

A method for purifying an antibody-like protein includes adsorbing an antibody-like protein onto an affinity separation matrix by bringing the antibody-like protein into contact with the affinity separation matrix; and eluting the antibody-like protein by bringing an eluent having a pH of 3.5 or higher into contact with the affinity separation matrix. The affinity separation matrix includes a carrier and a ligand immobilized on the carrier, and the ligand includes an amino acid sequence derived from a sequence selected from the group consisting of SEQ ID Nos: 1 to 5. Gln or Lys in an Fc-binding site of the amino acid sequence is substituted by Ala, Ser, or Thr, and the ligand has a lower antibody-binding capacity in an acidic pH range, as compared to a ligand including the amino acid sequence without the substitution.