Strategies for the assessment of protein aggregates in pharmaceutical biotech product development.
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.
den Engelsman
John
J
Biological and Sterile Product Development, MSD, Oss, The Netherlands.
Garidel
Patrick
P
Smulders
Ronald
R
Koll
Hans
H
Smith
Bryan
B
Bassarab
Stefan
S
Seidl
Andreas
A
Hainzl
Otmar
O
Jiskoot
Wim
W
D000911:Antibodies, Monoclonal / Q000737:chemistry / Q000276:immunology*; D001709:Biotechnology / Q000379:methods* / Q000592:standards; D004340:Drug Contamination / Q000517:prevention & control*; D055808:Drug Discovery / Q000379:methods* / Q000592:standards; D005062:European Union; D017408:Guidelines as Topic; D007118:Immunoassay; D017510:Protein Folding; D011786:Quality Control; D011994:Recombinant Proteins / Q000737:chemistry / Q000276:immunology*; D013678:Technology, Pharmaceutical / Q000379:methods* / Q000592:standards
D000911:Antibodies, Monoclonal; D011994:Recombinant Proteins