Antibody purification
AssigneePfizer Inc.
InventorsTimothy Iskra, Ashley Margaret Sacramo
Life of this patent
Estimating the term…
Abstract
Antibody compositions and methods for the purification of antibodies are provided. Purification methods provided involve the use of hydroxyapatite resin (HA) to separate an antibody of interest from one or more impurities.
Claims19
A composition comprising at least two proteins, an intact anti-BCMA/anti-CD3 bispecific antibody and a clipped version of the bispecific antibody, wherein
- (a) the bispecific antibody comprises an anti-BCMA arm and an anti-CD3 arm, the anti-CD3 arm comprises a VH region comprising an amino acid sequence as shown in SEQ ID NO:
- 1 and a VL region comprising an amino acid sequence as shown in SEQ ID NO:
- 3, and the anti-BCMA arm comprises a VH region comprising an amino acid sequence as shown in SEQ ID NO:
- 5 and a VL region comprising an amino acid sequence as shown in SEQ ID NO:
- 7;
- (b) the clipped version of the bispecific antibody has a molecular mass that is less than 1% different from the intact bispecific antibody;
- and that the composition comprises at least 90% by mass of the intact bispecific antibody of the proteins in the composition, and 0.1 to 5% by mass of the clipped version of the bispecific antibody of the proteins in the composition.
A composition comprising at least two proteins, an intact anti-BCMA/anti-CD3 bispecific antibody and a clipped version of the bispecific antibody, wherein
- (a) the bispecific antibody comprises an anti-BCMA arm and an anti-CD3 arm, the anti-CD3 arm comprises a heavy chain comprising an amino acid sequence as shown in SEQ ID NO:
- 2 and a light chain comprising an amino acid sequence as shown in SEQ ID NO:
- 4, and the anti-BCMA arm comprises a heavy chain comprising an amino acid sequence as shown in SEQ ID NO:
- 6 and a light chain comprising an amino acid sequence as shown in SEQ ID NO:
- 8;
- (b) the clipped version of the bispecific antibody has a molecular mass that is less than 1% different from the intact bispecific antibody;
- and that the composition comprises at least 90% by mass of the intact bispecific antibody of the proteins in the composition, and 0.1 to 5% by mass of the clipped version of the bispecific antibody of the proteins in the composition.
A method of purifying an antibody preparation comprising at least two proteins, an intact anti-BCMA/anti-CD3 bispecific antibody and a clipped version of the bispecific antibody, wherein:
- (a) the anti-CD3 arm of the intact bispecific antibody comprises (i) a VH region comprising an amino acid sequence as shown in SEQ ID NO:
- 1 and a VL region comprising an amino acid sequence as shown in SEQ ID NO:
- 3, or (ii) a heavy chain comprising an amino acid sequence as shown in SEQ ID NO:
- 2 and a light chain comprising an amino acid sequence as shown in SEQ ID NO:
- 4;
- (b) the anti-BCMA arm of the intact bispecific antibody comprises (i) a VH region comprising an amino acid sequence as shown in SEQ ID NO:
- 5 and a VL region comprising an amino acid sequence as shown in SEQ ID NO:
- 7, or (ii) a heavy chain comprising an amino acid sequence as shown in SEQ ID NO:
- 6 and a light chain comprising an amino acid sequence as shown in SEQ ID NO:
- 8, and
- (c) that the clipped version of the bispecific antibody has a molecular mass that is less than 1% different from the intact bispecific antibody;
- comprising the steps of:
- A) loading the antibody preparation in a load buffer onto a hydroxyapatite (HA) resin;
- and
- B) eluting the intact antibody of interest from the HA resin with an elution buffer.
Dependencies are inferred from the claim text.