Tungsten-induced denaturation and aggregation of epoetin alfa during primary packaging as a cause of immunogenicity. - Wikidata - awgldk - TriplyDB

Tungsten-induced denaturation and aggregation of epoetin alfa during primary packaging as a cause of immunogenicity.

Tungsten-induced denaturation and aggregation of epoetin alfa during primary packaging as a cause of immunogenicity.

http://www.wikidata.org/entity/Q41944133

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Immunogenicity of Biotherapeutics: Causes and Association with Posttranslational Modifications Early implementation of QbD in biopharmaceutical development: a practical example Physiology and pharmacology of erythropoietin Protein comparability assessments and potential applicability of high throughput biophysical methods and data visualization tools to compare physical stability profiles The approval process for biosimilar erythropoiesis-stimulating agents Incidence of erythropoietin antibody-mediated pure red cell aplasia: the Prospective Immunogenicity Surveillance Registry (PRIMS).Regulatory and clinical considerations for biosimilar oncology drugs Evaluation of Microflow Digital Imaging Particle Analysis for Sub-Visible Particles Formulated with an Opaque Vaccine Adjuvant Linking drugs to obscure illnesses: lessons from pure red cell aplasia, nephrogenic systemic fibrosis, and Reye's syndrome. a report from the Southern Network on Adverse Reactions (SONAR).Understanding the immunogenicity and antigenicity of nanomaterials: Past, present and future.Pure red cell aplasia induced by epoetin zeta.Safety issues related to erythropoiesis-stimulating agents used to treat anemia in patients with chronic kidney disease.Epoetin biosimilars in Europe: five years on.Differentiating factors between erythropoiesis-stimulating agents: an update to selection for anaemia of chronic kidney disease.Assessing immunogenicity of biosimilar therapeutic monoclonal antibodies: regulatory and bioanalytical considerations.Biopharmaceutical formulations for pre-filled delivery devices.Pharmacovigilance and biosimilars: considerations, needs and challenges.Managing unexpected events in the manufacturing of biologic medicines.Extractables and leachables considerations for prefilled syringes.Pre-filled syringes: a review of the history, manufacturing and challenges.State-of-the-art biosimilar erythropoietins in the management of renal anemia: lessons learned from Europe and implications for US nephrologists.Biosimilarity Versus Manufacturing Change: Two Distinct Concepts.Biosimilar infliximab for inflammatory bowel disease: from concepts to clinical practice. Case study illustrated with CT-P13.Comparative Effects of Metal-Catalyzed Oxidizing Systems on Carbonylation and Integrity of Therapeutic Proteins.The Safety of Erythropoiesis-Stimulating Agents for the Treatment of Anemia Resulting from Chronic Kidney Disease.History of Erythropoiesis-Stimulating Agents, the Development of Biosimilars, and the Future of Anemia Treatment in Nephrology.Mouse Models for Assessing Protein Immunogenicity: Lessons and Challenges.An overview on safety issues related to erythropoiesis-stimulating agents for the treatment of anaemia in patients with chronic kidney disease.Biosimilar epoetin zeta: extrapolation of indications and real world utilization experience.Biosimilar erythropoiesis-stimulating agents and the risk of developing anti-drug antibodies-a systematic review.The effect of exposure misclassification in spontaneous ADR reports on the time to detection of product-specific risks for biologicals: a simulation study.Interchangeability of Biosimilars: A European Perspective.Why the Immune System Should Be Concerned by Nanomaterials?Radar chart array analysis to visualize effects of formulation variables on IgG1 particle formation as measured by multiple analytical techniques.Aggregation risk prediction for antibodies and its application to biotherapeutic development.The Role of Aggregates of Therapeutic Protein Products in Immunogenicity: An Evaluation by Mathematical Modeling.New FDA draft guidance on immunogenicity.How bio-questionable are the different recombinant human erythropoietin copy products in Thailand?HX575: established biosimilarity in the treatment of renal anemia and 10 years of clinical experience.Epoetin Biosimilars in the Treatment of Chemotherapy-Induced Anemia: 10 Years' Experience Gained.

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P2860

Tungsten-induced denaturation and aggregation of epoetin alfa during primary packaging as a cause of immunogenicity.

http://www.wikidata.org/entity/Q41944133

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2011 nî lūn-bûn

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2011年の論文

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2011年論文

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2011年論文

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2011年论文

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Tungsten-induced denaturation ...... as a cause of immunogenicity.

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Tungsten-induced denaturation ...... as a cause of immunogenicity.

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Tungsten-induced denaturation ...... as a cause of immunogenicity.

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Pharmaceutical Research

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Tungsten-induced denaturation ...... as a cause of immunogenicity.

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Andreas Seidl

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Britta Deutel

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Gerard Michel London

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Iain Macdougall

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Jörg Windisch

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Marleen Richter

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Martin Hartinger

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Nicole Casadevall

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Otmar Hainzl

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Robert Fischer

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P2860

Structural characterization and immunogenicity in wild-type and immune tolerant mice of degraded recombinant human interferon alpha2b.

Degradation products of factor VIII which can lead to increased immunogenicity.

Immune responses to therapeutic proteins in humans--clinical significance, assessment and prediction.

Antibody-mediated pure red cell aplasia (PRCA): epidemiology, immunogenicity and risks.

Factors influencing the immunogenicity of therapeutic proteins.

Effects of protein aggregates: an immunologic perspective

Immunogenicity of therapeutic proteins. Part 3: impact of manufacturing changes.

Precipitation of a monoclonal antibody by soluble tungsten

Strategies for the assessment of protein aggregates in pharmaceutical biotech product development

Overlooking subvisible particles in therapeutic protein products: gaps that may compromise product quality.

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29

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22094831

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