Analytical aspects of biosimilarity issues of protein drugs.
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Update on the safety and bioequivalence of biosimilars - focus on enoxaparin.Correct primary structure assessment and extensive glyco-profiling of cetuximab by a combination of intact, middle-up, middle-down and bottom-up ESI and MALDI mass spectrometry techniques.The criticality of high-resolution N-linked carbohydrate assays and detailed characterization of antibody effector function in the context of biosimilar development.Similar biotherapeutic products: overview and reflections.Recent advances in combination of capillary electrophoresis with mass spectrometry: methodology and theory.Biosimilar regulation in the EU.Biosimilars for psoriasis: preclinical analytical assessment to determine similarity.Biosimilars for psoriasis: clinical studies to determine similarity.Scale-Up of Protein Purification: Downstream Processing Issues.Approval of the first biosimilar antibodies in Europe: a major landmark for the biopharmaceutical industry.2D (1)H(N), (15)N Correlated NMR Methods at Natural Abundance for Obtaining Structural Maps and Statistical Comparability of Monoclonal Antibodies.Microplate-Based Method for High-Throughput Screening (HTS) of Chromatographic Conditions Studies for Recombinant Protein Purification.
P2860
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Analytical aspects of biosimilarity issues of protein drugs.
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article científic
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article scientifique
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articol științific
@ro
articolo scientifico
@it
artigo científico
@gl
artigo científico
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artigo científico
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artikel ilmiah
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artikull shkencor
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artículo científico
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name
Analytical aspects of biosimilarity issues of protein drugs.
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type
label
Analytical aspects of biosimilarity issues of protein drugs.
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prefLabel
Analytical aspects of biosimilarity issues of protein drugs.
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P2093
P1476
Analytical aspects of biosimilarity issues of protein drugs.
@en
P2093
Katalin Ganzler
Marcell Olajos
Zsuzsanna Kálmán-Szekeres
P304
P356
10.1016/J.JPBA.2012.04.037
P577
2012-05-03T00:00:00Z