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Detection of innate immune response modulating impurities (IIRMI) in therapeutic peptides and proteins: Impact of excipients.
Thacker SG, Her C, Kelley-Baker L, Ireland DDC, Manangeeswaran M, Pang ES, Verthelyi D. Thacker SG, et al. Front Immunol. 2022 Sep 6;13:970499. doi: 10.3389/fimmu.2022.970499. eCollection 2022. Front Immunol. 2022. PMID: 36148237 Free PMC article.
Product- and process- related impurities can act as adjuvants that activate the local or systemic innate immune response increasing the likelihood of product immunogenicity. Thus, assessing whether products have innate immune response …
Product- and process- related impurities can act as adjuvants that activate the local or systemic innate immune resp …
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. ...Here we used purified PRR agonists as model impurities to assess the minimal level of individual innate immune response modulati …
Unwanted immune responses to therapeutic proteins can severely impact their safety and efficacy. ...Here we used purifi …
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. ...
Therapeutic proteins can induce immune responses that affect their safety and efficacy. Product aggregates and innat …