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Low pH virus inactivation performed on a chromatography column

IP.com Disclosure Number: IPCOM000183319D
Publication Date: 2009-May-18
Document File: 1 page(s) / 56K

Publishing Venue

The IP.com Prior Art Database

Abstract

A virus inactivation step is included in almost all downstream monoclonal antibody (MAb) processes after the Protein A step. The virus inactivation is almost exclusively done in batch mode, in a stir-tank. After the virus inactivation step the pH is adjusted to fit the unit operation to follow, often a column chromatography step. By combining two unit operations, virus inactivation and cat-ion exchange (CIEX) chromatography, the number of unit operations in the process as well as the number of tanks needed in the process are reduced.

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Low pH virus inactivation performed on a chromatography column

A virus inactivation step is included in almost all downstream monoclonal antibody (MAb) processes. This step is placed after the Protein A step, this because the product at this stage already is in low pH. The virus inactivation is performed during a time somewhere between 30 and 60 minutes, at a pH of 3.6-
3.8. It is almost exclusively done in batch mode, in a stir-tank. After the virus inactivation step the pH is adjusted to fit the unit operation to follow, often a column chromatography step.

By combining two unit operations, virus inactivation and cat-ion exchange (CIEX) chromatography one can reduce the number of unit operations in the process at the same time as one by doing this reduce the number of tanks needed in the process. Instead of eluting the MAb from the Protein A resin into a tank it can be eluted directly onto a CIEX column. The CIEX column should, after the MAb has been bound to the column, be adjusted to a pH between 3.6 and 3.8. After the MAb has been bound to the CIEX column for 30-60 minutes the MAb should be eluted from the resin in a normal fashion, i.e. with increased ionic strength.

The process modification would eliminate one tank used in the process. Another advantage is that the MAb when bound to the column are less likely to form aggregates; dimers and larger aggregates.

This approach, combining unit operations, could be considere...