Automated ELISA for potency measurements of therapeutic antibodies and antibody fragments

Author:

Rey Guillaume,Schuetz Fabienne,Schroeder Daniela,Kaluschke Christian,Wendeler Markus W.,Hofmann Irmgard,Dumbliauskas Eva,Obrdlik Petr

Funder

Novartis

Publisher

Elsevier BV

Reference21 articles.

1. First Supplement to USP 35–NF 30, <1032>, Design and Development of Biological Assays, in: United States Pharmacopeia, National Formulary (USP-NF), First supplement, United States Pharmacopeial Convention, Rockville (MD), 2012: pp. 5160–5174.

2. 5.3 Statistical Analysis of Results of Biological Assays and Tests, in: European Pharmacopeia, Council of Europe’s European Directorate for the Quality of Medicines and HealthCare (EDQM), Strasbourg, 2008: pp. 571–600.

3. First Supplement to USP 35-NF 30, <1034>, Analysis of Biological Assays, in: United States Pharmacopeia, National Formulary (USP-NF), United States Pharmacopeial Convention, Rockville (MD), 2012.

4. Strategies to minimize variability and bias associated with manual pipetting in ligand binding assays to assure data quality of protein therapeutic quantification;Pandya;J. Pharm. Biomed. Anal.,2010

5. Semi-automation of process analytics reduces operator effect;Christler;Bioprocess Biosyst. Eng.,2020

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