caa a22 4500 445313331 CHVBK 20180317142637.0 cr unu---uuuuu 170323e20110401xx s 000 0 eng 10.1007/s11095-010-0297-1 doi (NATIONALLICENCE)springer-10.1007/s11095-010-0297-1 Strategies for the Assessment of Protein Aggregates in Pharmaceutical Biotech Product Development [Elektronische Daten] [John den Engelsman, Patrick Garidel, Ronald Smulders, Hans Koll, Bryan Smith, Stefan Bassarab, Andreas Seidl, Otmar Hainzl, Wim Jiskoot] ABSTRACT: Within the European Immunogenicity Platform (EIP) (http://www.e-i-p.eu), the Protein Characterization Subcommittee (EIP-PCS) has been established to discuss and exchange experience of protein characterization in relation to unwanted immunogenicity. In this commentary, we, as representatives of EIP-PCS, review the current state of methods for analysis of protein aggregates. Moreover, we elaborate on why these methods should be used during product development and make recommendations to the biotech community with regard to strategies for their application during the development of protein therapeutics. The Author(s), 2010 aggregation nationallicence aggregates nationallicence analytical characterization nationallicence biotech products nationallicence commentary nationallicence drug development nationallicence particles nationallicence proteins nationallicence recommendation nationallicence den Engelsman John Biological and Sterile Product Development, MSD, Oss, The Netherlands aut Garidel Patrick Boehringer Ingelheim Pharma GmbH & Co. KG, Department of Process Science/Biopharmaceuticals, Biberach an der Riss, Germany aut Smulders Ronald Biological and Sterile Product Development, MSD, Oss, The Netherlands aut Koll Hans Biologics Research - Protein Analytics, Roche Pharma Research and Early Development, Penzberg, Germany aut Smith Bryan UCB, Slough, Berkshire, UK aut Bassarab Stefan Boehringer Ingelheim Pharma GmbH & Co. KG, Department of Process Science/Biopharmaceuticals, Biberach an der Riss, Germany aut Seidl Andreas Sandoz Biopharmaceuticals, Analytical Characterization, Hexal AG, Oberhaching, Germany aut Hainzl Otmar Sandoz Biopharmaceuticals, Analytical Characterization, Hexal AG, Oberhaching, Germany aut Jiskoot Wim Division of Drug Delivery Technology Leiden/Amsterdam Center for Drug Research, Leiden University, P.O. Box9502, 2300 RA, Leiden, The Netherlands aut Pharmaceutical Research Springer US; http://www.springer-ny.com 28/4(2011-04-01), 920-933 0724-8741 28:4<920 2011 28 11095 https://doi.org/10.1007/s11095-010-0297-1 text/html Onlinezugriff via DOI 1 research-article jats NATIONALLICENCE 856 40 https://doi.org/10.1007/s11095-010-0297-1 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- den Engelsman John Biological and Sterile Product Development, MSD, Oss, The Netherlands aut NATIONALLICENCE 700 1- Garidel Patrick Boehringer Ingelheim Pharma GmbH & Co. KG, Department of Process Science/Biopharmaceuticals, Biberach an der Riss, Germany aut NATIONALLICENCE 700 1- Smulders Ronald Biological and Sterile Product Development, MSD, Oss, The Netherlands aut NATIONALLICENCE 700 1- Koll Hans Biologics Research - Protein Analytics, Roche Pharma Research and Early Development, Penzberg, Germany aut NATIONALLICENCE 700 1- Smith Bryan UCB, Slough, Berkshire, UK aut NATIONALLICENCE 700 1- Bassarab Stefan Boehringer Ingelheim Pharma GmbH & Co. KG, Department of Process Science/Biopharmaceuticals, Biberach an der Riss, Germany aut NATIONALLICENCE 700 1- Seidl Andreas Sandoz Biopharmaceuticals, Analytical Characterization, Hexal AG, Oberhaching, Germany aut NATIONALLICENCE 700 1- Hainzl Otmar Sandoz Biopharmaceuticals, Analytical Characterization, Hexal AG, Oberhaching, Germany aut NATIONALLICENCE 700 1- Jiskoot Wim Division of Drug Delivery Technology Leiden/Amsterdam Center for Drug Research, Leiden University, P.O. Box9502, 2300 RA, Leiden, The Netherlands aut NATIONALLICENCE 773 0- Pharmaceutical Research Springer US; http://www.springer-ny.com 28/4(2011-04-01), 920-933 0724-8741 28:4<920 2011 28 11095 Metadata rights reserved Springer special CC-BY-NC licence nationallicence BK010053 XK010053 XK010000 NATIONALLICENCE NATIONALLICENCE NL-springer