METHOD OF DETERMINING THE MOLECULAR WEIGHT DISTRIBUTION OF GLATIRAMER ACETATE USING MULTI-ANGLE LASER LIGHT SCATTERING (MALLS)

The present, invention provides a process for characterizing a glatiramer acetate related drug substance (GARDS) or a glatiramer acetate related drug product (GARDP) comprising separating a batch of a GARDS or GARDP according to hydrophobicity and determining the molar mass of the separated material...

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Bibliographic Details
Main Authors PINKERT, Dalia, KOMLOSH, Avraham, Arthur
Format Patent
LanguageEnglish
French
Published 30.11.2017
Subjects
CHEMISTRY
HUMAN NECESSITIES
HYGIENE
INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIRCHEMICAL OR PHYSICAL PROPERTIES
MEASURING
MEDICAL OR VETERINARY SCIENCE
METALLURGY
ORGANIC CHEMISTRY
PEPTIDES
PHYSICS
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
TESTING
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Summary:The present, invention provides a process for characterizing a glatiramer acetate related drug substance (GARDS) or a glatiramer acetate related drug product (GARDP) comprising separating a batch of a GARDS or GARDP according to hydrophobicity and determining the molar mass of the separated material, thereby characterizing the GARDS or GARDP by molar mass as a function of hydrophobicity. La présente invention concerne un procédé permettant de caractériser une substance médicamenteuse associée à l'acétate de glatiramère (GARDS pour Glatiramer Acetate Related Drug Substance) ou un produit médicamenteux associé à l'acétate de glatiramère (GARDP pour Glatiramer Acetate Related Drug Product) consistant à séparer un lot d'une substance GARDS ou d'un produit GARDP en fonction de l'hydrophobicité et à déterminer la masse molaire de la substance séparée, ce qui permet de caractériser la substance GARDS ou le produit GARDP par la masse molaire en fonction de l'hydrophobicité.
Bibliography:Application Number: WO2016US30277