Saturday, February 24, 2018 7:48:20 AM
GLYCAN OXONIUM ION PROFILING OF GLYCOSYLATED PROTEINS 2018-02-22
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.
https://worldwide.espacenet.com/publicationDetails/biblio?DB=EPODOC&II=0&ND=3&adjacent=true&locale=en_EP&FT=D&date=20180222&CC=WO&NR=2018035350A1&KC=A1
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On MNTA site - updated as of 2018-1-26
Novel Drugs for Autoimmune Indications
Autoimmune diseases result from a dysfunction of the immune system in which the body attacks its own organs, tissues, and cells. To date, physicians and scientists have identified more than 80 clinically distinct autoimmune diseases1. Several are well known, including rheumatoid arthritis, multiple sclerosis, type 1 diabetes, and systemic lupus erythematosus; others are less familiar, including myasthenia gravis, Sjögren’s syndrome, dermatomyositis, and pemphigus. Collectively, these diseases, as a category, affect 50 million Americans1. Additionally, autoimmune diseases are reported to be on the rise in the U.S. and around the world, making this poorly understood category of disease a public health crisis at levels comparable to heart disease and cancer.
http://www.momentapharma.com/pipeline/novel-autoimmune-drugs.php
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