Host cell protein-mediated adjuvanticity and immunogenicity risks of biotherapeutics
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Author (Corporation)
Publication date
07.2025
Type of student thesis
Course of study
Type
01A - Journal article
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Parent work
Biotechnology Advances
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Series number
Volume
81
Issue / Number
Pages / Duration
108575
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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-reviewed
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