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Detection of innate immune response modulating impurities in therapeutic proteins.
Haile LA, Puig M, Kelley-Baker L, Verthelyi D. Haile LA, et al. PLoS One. 2015 Apr 22;10(4):e0125078. doi: 10.1371/journal.pone.0125078. eCollection 2015. PLoS One. 2015. PMID: 25901912 Free PMC article.
Currently, while products are tested for host cell protein content, assays to control innate immune response modulating impurities (IIRMIs) in products are focused mainly on endotoxin and nucleic acids, however, depending on the cell subs …
Currently, while products are tested for host cell protein content, assays to control innate immune response
In Vivo Effect of Innate Immune Response Modulating Impurities on the Skin Milieu Using a Macaque Model: Impact on Product Immunogenicity.
Haile LA, Puig M, Polumuri SK, Ascher J, Verthelyi D. Haile LA, et al. J Pharm Sci. 2017 Mar;106(3):751-760. doi: 10.1016/j.xphs.2016.11.001. Epub 2016 Dec 4. J Pharm Sci. 2017. PMID: 27923493
Unwanted immune responses to therapeutic proteins can severely impact their safety and efficacy. Studies show that the presence of trace amounts of host cells and process-related impurities that stimulate pattern recognition receptors (PRR) can cause l …
Unwanted immune responses to therapeutic proteins can severely impact their safety and efficacy. Studies show that the …
Aggregates of IVIG or Avastin, but not HSA, modify the response to model innate immune response modulating impurities.
Polumuri SK, Haile LA, Ireland DDC, Verthelyi D. Polumuri SK, et al. Sci Rep. 2018 Jul 31;8(1):11477. doi: 10.1038/s41598-018-29850-4. Sci Rep. 2018. PMID: 30065306 Free PMC article.
Therapeutic proteins can induce immune responses that affect their safety and efficacy. Product aggregates and innate immune response modulating impurities (IIRMI) are risk factors of product immunogenicity. In this study, w
Therapeutic proteins can induce immune responses that affect their safety and efficacy. Product aggregates and innat
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