Answers to Your Questions on Immunogenicity Testing for Biosimilars: Part 2
BioAgilytix’s Todd Lester answers additional questions submitted by attendees of his recent Bioanalysis Zone webinar on immunogenicity testing for biosimilars.
BioAgilytix’s Todd Lester answers additional questions submitted by attendees of his recent Bioanalysis Zone webinar on immunogenicity testing for biosimilars.
BioAgilytix’s Todd Lester answers questions submitted by attendees of his recent Bioanalysis Zone webinar on immunogenicity testing for biosimilars.
A new clinical trial by St. Jude Children’s Research Hospital for the treatment of SCID-X1 highlights a major advancement in gene therapy safety over recent years, in this case spurred by scientists who were courageous enough to push forward the development of safer vectors to overcome serious adverse events (SAEs) that were resulting from the previous generation of gene therapies developed for SCID-X1.
We discuss the need to put phase-appropriate methods in place to identify and quantify both process- and host-cell related impurities throughout the drug development process.
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