The present invention provides methods for isolating an active polypeptide or immunoconjugate by purification of a solution containing both the active polypeptide or immunoconjugate and an acidic variant thereof, such as a deamidated variant, using anion exchange chromatography. The present invention also provides compositions, formulations, and unit dosage forms comprising the purified polypeptide or immunoconjugate.

The present invention provides methods for isolating an active polypeptide or immunoconjugate by purification of a solution containing both the active polypeptide or immunoconjugate and an acidic variant thereof, such as a deamidated variant, using anion exchange chromatography. The present invention also provides compositions, formulations, and unit dosage forms comprising the purified polypeptide or immunoconjugate.

An ion exchange chromatography column contains an ion exchange stationary phase that includes a charged substrate, a plurality of first particles, and a plurality of second particles. The plurality of first particles each include first ion exchange groups and the first particles are ionically bound to the charged substrate. The plurality of second particles each include second ion exchange groups and the second particles are ionically bound to the charged substrate. The first particles having a first ion exchange group density, and the second particles having a second ion exchange group density. The first ion exchange group density is greater than the second ion exchange group density. The ion exchange chromatography column has a number of zones connected in series where each zone can have a varying level of first ion exchange groups and second ion exchange group from the inlet zone to the outlet zone.

An ion exchange chromatography column contains an ion exchange stationary phase that includes a charged substrate, a plurality of first particles, and a plurality of second particles. The plurality of first particles each include first ion exchange groups and the first particles are ionically bound to the charged substrate. The plurality of second particles each include second ion exchange groups and the second particles are ionically bound to the charged substrate. The first particles having a first ion exchange group density, and the second particles having a second ion exchange group density. The first ion exchange group density is greater than the second ion exchange group density. The ion exchange chromatography column has a number of zones connected in series where each zone can have a varying level of first ion exchange groups and second ion exchange group from the inlet zone to the outlet zone.

A method for modifying a polymer carrier material for use as a stationary phase in an analytical or preparative separating method, the method comprising the steps of: providing a polymer carrier material, which is at least partly formed of aromatic hydrocarbon compounds comprising at least two vinyl or allyl substituents; producing hydroxy groups on/in the polymer carrier material by a method comprising an oxidative treatment of the polymer carrier material and a subsequent reductive or hydrolytic treatment of the reaction product; reacting the product from the previous step with a polyfunctional compound. The invention also relates to a polymer carrier material for use as a stationary phase in an analytical or preparative separating method, in particular a chromatography method, produced according to a method according to the invention.

A method for modifying a polymer carrier material for use as a stationary phase in an analytical or preparative separating method, the method comprising the steps of: providing a polymer carrier material, which is at least partly formed of aromatic hydrocarbon compounds comprising at least two vinyl or allyl substituents; producing hydroxy groups on/in the polymer carrier material by a method comprising an oxidative treatment of the polymer carrier material and a subsequent reductive or hydrolytic treatment of the reaction product; reacting the product from the previous step with a polyfunctional compound. The invention also relates to a polymer carrier material for use as a stationary phase in an analytical or preparative separating method, in particular a chromatography method, produced according to a method according to the invention.

The present invention provides methods for cleaning or regenerating a chromatography material for reuse. The methods of the invention can be used for cleaning or regenerating ion exchange chromatography columns for reuse in the large-scale manufacture of multiple polypeptide products where the ion exchange chromatography column in used in overload mode.

The present invention provides methods for cleaning or regenerating a chromatography material for reuse. The methods of the invention can be used for cleaning or regenerating ion exchange chromatography columns for reuse in the large-scale manufacture of multiple polypeptide products where the ion exchange chromatography column in used in overload mode.

A process is described for the separation of at least one inositol from a carob extract. The carob extract is filtered and demineralized, and has a Brix value greater than 60 and a pinitol content of 5 to 25 wt %. The carob extract is subjected to chromatographic separation which involves at least one passage on a chromatographic resin. This produces an aqueous solution comprising 35 to 70 wt % pinitol and a Brix value of 20 or lower. The aqueous solution is then purified to obtain a purified aqueous solution having a pinitol content of more than 55%.

A chromatography system comprising at least two chromatography units (3) connected in parallel, wherein said at least two chromatography units (3) each comprises a convection-based chromatography material, wherein an initial difference in back pressure provided from the different chromatography units (3) is compensated dynamically during run of the system due to a change of chromatography unit properties provided during the chromatography process.