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US 2021/0333288 A1Published application
Glycan oxonium ion profiling of glycosylated proteins
AssigneeMomenta Pharmaceuticals, Inc.
InventorsJames Madsen, Victor Farutin
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AssigneeMomenta Pharmaceuticals, Inc.
InventorsJames Madsen, Victor Farutin
Estimating the term…
Methods disclosed herein include an improved technique for comparing a glycosylation profile of a first protein (e.g., an innovator protein drug) with a glycosylation profile of a second protein (e.g., a corresponding biogeneric/biosimilar). For example, a method of manufacture can include providing or obtaining a batch of a test glycoprotein drug substance, using mass spectrometry to acquire a test oxonium ion profile from a sample of the test glycoprotein drug substance batch, comparing the test oxonium ion profile to a corresponding target oxonium ion profile of a target glycoprotein drug product, and processing the batch of the test glycoprotein drug substance as a drug product if the difference between the test oxonium ion profile and the corresponding target oxonium ion profile is tolerable, or taking an alternative action if the difference between the test oxonium ion profile and the target oxonium ion profile is not tolerable.
A method of manufacture, comprising:
The method of any one of the preceding claims, wherein the target glycoprotein drug product is approved under a primary approval process.
The method of any one of the preceding claims, wherein the target glycoprotein drug product is approved under a BLA.
The method of any one of the preceding claims, wherein using mass spectrometry comprises digesting the sample to produce a plurality of glycopeptides and/or glycans.
The method of any one of the preceding claims, wherein using mass spectrometry comprises performing liquid chromatography-tandem mass spectrometry.
The method of any one of the preceding claims, wherein using mass spectrometry comprises performing data-independent mass spectrometry.
The method of any one of the preceding claims, wherein using mass spectrometry comprises performing all ion fragmentation.
The method of any one of the preceding claims, wherein the test oxonium ion profile comprises one or more MS signals associated with levels of oxonium ion-containing fragments that include the following oxonium ions:
The method of any one of the preceding claims, wherein the test oxonium ion profile comprises one or more MS signals associated with levels of oxonium ion-containing fragments that include oxonium ions having the following m/z values as well as any associated isotope peaks:
The method of any one of the preceding claims, further comprising producing a representation of the comparison of the test oxonium ion profile to the target oxonium ion profile.
The method of any one the preceding claims, further comprising using mass spectrometry to acquire a target oxonium ion profile of the target glycoprotein drug product.
The method of any one of the preceding claims, wherein the difference between the test oxonium ion profile and the corresponding target oxonium ion profile is tolerable if the difference between a level of at least one oxonium ion-containing fragment derived from the test oxonium ion profile and a level of at least one oxonium ion-containing fragment derived from the corresponding target oxonium ion profile is less than a predetermined value.
The method of any one of the preceding claims, wherein the alternative action comprises disposing of the batch of the test glycoprotein drug substance, classifying for disposal the batch of the test glycoprotein drug substance, labeling the batch of the test glycoprotein drug substance for disposal, reprocessing the batch of the test glycoprotein drug substance or a combination thereof.
The method of any one of the preceding claims, wherein the processing step comprises:
Dependencies are inferred from the claim text.