Host cell protein-mediated adjuvanticity and immunogenicity risks of biotherapeutics
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Author (Corporation)
Publication date
07.2025
Typ of student thesis
Course of study
Type
01A - Journal article
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Supervisor
Parent work
Biotechnology Advances
Special issue
DOI of the original publication
Link
Series
Series number
Volume
81
Issue / Number
Pages / Duration
108575
Patent number
Publisher / Publishing institution
Elsevier
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Abstract
Host cell proteins (HCPs) are process-related impurities of biotherapeutic production that might affect product quality and/or patient safety. In a few cases, adverse events were attributed to HCPs present in the administered biotherapeutic. HCP-associated immune risks include adjuvanticity and immunogenicity with potential cross-reactivity. Based on the published data, some HCPs can act as adjuvants increasing the immunogenicity of the biotherapeutic as a bystander effect. HCPs may also induce immunogenicity against themselves, resulting in anti-HCP T cell responses and anti-HCP antibody formation. Depending on sequence similarities, these anti-HCP immune responses might theoretically be cross-reactive to the biotherapeutic or human endogenous proteins. In this review, we examine HCP-associated immune-related risks reported from non-clinical and clinical studies. We also discuss the potential and limitations of in vitro and in silico methods to evaluate the adjuvanticity and immunogenicity potential of HCPs. A risk-based assessment of the safety impact of HCPs may include the identity of the HCP and similarity to the biotherapeutic and human proteins, as well as product, treatment-, and patient-related factors.
Keywords
Adjuvanticity, Biotherapeutics, Cross-reactivity, Host cell proteins, Immunogenicity, Monoclonal antibody
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ISBN
ISSN
0734-9750
1873-1899
1873-1899
Language
English
Created during FHNW affiliation
Yes
Strategic action fields FHNW
Publication status
Published
Review
Peer review of the complete publication
Open access category
Closed
License
Citation
Panikulam, S., Morgan, H., Gutknecht, M., Villiger, T., Lebesgue, N., & Karle, A. C. (2025). Host cell protein-mediated adjuvanticity and immunogenicity risks of biotherapeutics. Biotechnology Advances, 81, 108575. https://doi.org/10.1016/j.biotechadv.2025.108575