Anti-tslp antibody compositions and uses thereof
AssigneeAmgen Inc.
InventorsHao Zhang, Alla Polozova, Kelly Fitzpatrick, Kristin Abrams, Dong Xiang, Marisa K. Joubert
Life of this patent
Estimating the term…
Abstract
The present application relates, in general, to compositions comprising anti-TSLP antibody tezepelumab and derivatives thereof having antibody quality attributes.
Claims89
A composition comprising tezepelumab and one or more tezepelumab derivatives, wherein the one or more tezepelumab derivatives comprise an isomerization derivative, and wherein the amount of the isomerization derivative in the composition is less than about 30%, wherein tezepelumab comprises
- A) a light chain variable domain comprising:
- (i) a light chain CDR1 amino acid sequence set out in SEQ ID NO:3;
- (ii) a light chain CDR2 amino acid sequence set out in SEQ ID NO:
- 4;
- and
- (iii) a light chain CDR3 amino acid sequence set out in SEQ ID NO:5;
- and
- (B) a heavy chain variable domain comprising:
- (i) a heavy chain CDR1 amino acid sequence set out in SEQ ID NO:6;
- (ii) a heavy chain CDR2 amino acid sequence set out in SEQ ID NO:7 and
- (iii) a heavy chain CDR3 amino acid sequence set out in SEQ ID NO:8.
A composition comprising tezepelumab and one or more tezepelumab derivatives, wherein the one or more tezepelumab derivatives comprise a deamidation derivative, and wherein the amount of the deamidation derivative in the composition is less than about 15%, wherein tezepelumab comprises
- A) a light chain variable domain comprising:
- (i) a light chain CDR1 amino acid sequence set out in SEQ ID NO:3;
- (ii) a light chain CDR2 amino acid sequence set out in SEQ ID NO:
- 4;
- and
- (iii) a light chain CDR3 amino acid sequence set out in SEQ ID NO:5;
- and
- (B) a heavy chain variable domain comprising:
- (i) a heavy chain CDR1 amino acid sequence set out in SEQ ID NO:6;
- (ii) a heavy chain CDR2 amino acid sequence set out in SEQ ID NO:7 and
- (iii) a heavy chain CDR3 amino acid sequence set out in SEQ ID NO:8.
A composition comprising tezepelumab and one or more tezepelumab derivatives, wherein the one or more tezepelumab derivatives comprises an oxidation derivative, and wherein the amount of the oxidation derivative in the composition is less than about 7%, wherein tezepelumab comprises
- A) a light chain variable domain comprising:
- (i) a light chain CDR1 amino acid sequence set out in SEQ ID NO:3;
- (ii) a light chain CDR2 amino acid sequence set out in SEQ ID NO:
- 4;
- and
- (iii) a light chain CDR3 amino acid sequence set out in SEQ ID NO:5;
- and
- (B) a heavy chain variable domain comprising:
- (i) a heavy chain CDR1 amino acid sequence set out in SEQ ID NO:6;
- (ii) a heavy chain CDR2 amino acid sequence set out in SEQ ID NO:7 and
- (iii) a heavy chain CDR3 amino acid sequence set out in SEQ ID NO:8.
A composition comprising tezepelumab and one or more tezepelumab derivatives, wherein the one or more tezepelumab derivatives are high molecular weight (HMW) species, and wherein the amount of the HMW species in the composition is less than about 20%, wherein tezepelumab comprises
- A) a light chain variable domain comprising:
- (i) a light chain CDR1 amino acid sequence set out in SEQ ID NO:3;
- (ii) a light chain CDR2 amino acid sequence set out in SEQ ID NO:
- 4;
- and
- (iii) a light chain CDR3 amino acid sequence set out in SEQ ID NO:5;
- and
- (B) a heavy chain variable domain comprising:
- (i) a heavy chain CDR1 amino acid sequence set out in SEQ ID NO:6;
- (ii) a heavy chain CDR2 amino acid sequence set out in SEQ ID NO:7;
- and
- (iii) a heavy chain CDR3 amino acid sequence set out in SEQ ID NO:8.
A composition comprising tezepelumab and one or more tezepelumab derivatives, wherein the one or more tezepelumab derivatives comprise a tezepelumab fragment, and wherein the amount of the tezepelumab fragment in the composition is less than about 15%, wherein tezepelumab comprises
- (A) a light chain variable domain comprising:
- (i) a light chain CDR1 amino acid sequence set out in SEQ ID NO:3;
- (ii) a light chain CDR2 amino acid sequence set out in SEQ ID NO:
- 4;
- and
- (iii) a light chain CDR3 amino acid sequence set out in SEQ ID NO:5;
- and
- (B) a heavy chain variable domain comprising:
- (i) a heavy chain CDR1 amino acid sequence set out in SEQ ID NO:6;
- (ii) a heavy chain CDR2 amino acid sequence set out in SEQ ID NO:7 and
- (iii) a heavy chain CDR3 amino acid sequence set out in SEQ ID NO:8.
A composition comprising tezepelumab and one or more tezepelumab derivatives, wherein the one or more tezepelumab derivatives comprises a glycosylation derivative, and wherein the amount of the glycosylation derivative in the composition is less than about 40%, wherein tezepelumab comprises
- (A) a light chain variable domain comprising:
- (i) a light chain CDR1 amino acid sequence set out in SEQ ID NO:3;
- (ii) a light chain CDR2 amino acid sequence set out in SEQ ID NO:
- 4;
- and
- (iii) a light chain CDR3 amino acid sequence set out in SEQ ID NO:5;
- and
- (B) a heavy chain variable domain comprising:
- (i) a heavy chain CDR1 amino acid sequence set out in SEQ ID NO:6;
- (ii) a heavy chain CDR2 amino acid sequence set out in SEQ ID NO:7 and
- (iii) a heavy chain CDR3 amino acid sequence set out in SEQ ID NO:8.
A composition comprising tezepelumab and one or more disulfide isoform derivatives thereof, wherein the one or more disulfide isoform derivatives comprise an IgG2-B isoform and or an IgG2-A/B isoform, and wherein the amount of the disulfide isoform derivative in the composition is less than about 75%.
A composition comprising tezepelumab and one or more tezepelumab derivatives, wherein the tezepelumab derivatives comprise isomerization derivatives, deamidation derivatives, oxidation derivatives, glycosylation derivatives, HMW species, fragments, disulfide isoform derivatives or combinations thereof, wherein the composition has one or more of the following characteristics:
- (a) the amount of isomerization derivatives in the composition is about 30% or less as measured by reduced peptide mapping;
- (b) the amount of deamidation derivatives in the composition is about 15% or less as measured by peptide mapping;
- (c) the amount of oxidation derivatives in the composition is about 7% or less as measured by reduced peptide mapping;
- (d) the amount of glycosylation derivatives in the composition is about 40% or less as measured by glycan mapping;
- (e) the amount of disulfide isoform derivatives in the composition is about 75% or less as measured by non-reduced reversed phase high performance liquid chromatography (RP-HPLC);
- (f) the amount of HMW species in the composition is about 20% or less as measured by SE-HPLC;
- and/or
- (g) the amount of fragments in the composition is about 15% or less as measured by rCE-SDS.
A method for assessing the quality of a tezepelumab composition, comprising:
- obtaining a tezepelumab composition that contains tezepelumab and one or more tezepelumab derivatives;
- measuring the amount of one or more tezepelumab derivatives in the composition, wherein the tezepelumab derivatives comprise isomerization derivatives, deamidation derivatives, oxidation derivatives, glycosylation derivatives, disulfide isoform derivatives, HMW species, fragments, or combinations thereof;
- comparing the measured amount of the one or more tezepelumab derivatives to a pre-determined reference criterion;
- and
- preparing a pharmaceutical formulation or pharmaceutical product of the tezepelumab composition if the comparison indicates that the pre-determined reference criterion is met.
Dependencies are inferred from the claim text.