Methods of reducing polysorbate degradation in drug formulations
OwnerHui Xiao, Sisi Zhanginventors
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Abstract
The present disclosure pertains to compositions with reduced residual amount of lipases and methods of making such compositions. In particular, it pertains to compositions and methods of such making compositions by depleting the compositions of certain lipases, such as, liver carboxylesterase B-1-like protein and liver carboxylesterase 1-like protein.
Claims55
A method of depleting lipase from a sample, comprising:
- contacting the sample including lipase with a probe, said probe capable of binding to the lipase to form a complex;
- and
- separating the complex from the sample to thereby deplete the lipase from the sample
A method of a method of purifying a sample having a protein of interest and a lipase, comprising:
- contacting the sample with a probe, said probe capable of binding to the lipase to form a complex;
- and
- separating the complex from the sample to thereby purify the protein of interest in the sample.
A method of decreasing degradation of polysorbate in a sample, comprising
- contacting the sample including lipase and polysorbate with a probe, said probe capable of binding to the lipase to form a complex;
- and
- separating the complex from the sample to thereby decreasing degradation of polysorbate in the sample.
A composition having a protein of interest purified from mammalian cells, surfactant and a residual amount of liver carboxylesterase B-1-like protein, wherein the residual amount of liver carboxylesterase B-1-like protein is less than about 5 ppm.
A composition having a protein of interest purified from mammalian cells, surfactant and a residual amount of liver carboxylesterase 1-like protein, wherein the residual amount of lysosomal acid lipase is less than about 5 ppm.
Dependencies are inferred from the claim text.