AI Prediction + Experimental Validation | Hycells Leverages the WeMol Platform for Precise Immunogenicity Assessment
Release Date:
2025-05-19 15:11
Generation and Hazards of Immunogenicity
Immunogenicity It refers to the ability of a drug or its metabolites to elicit an immune response in the organism. For therapeutic protein drugs, such as antibodies and vaccines, the induction of immunogenicity involves complex multi-factorial interactions, primarily including:
1. Pharmacological factors:
Amino acid sequence: Non-human-derived drugs or those with altered amino acid sequences are more likely to elicit immune responses.
Structural modifications, such as sialylation, deglycosylation, and fusion protein engineering, may increase the risk of immunogenicity.
2. Product Process:
Impurities: Impurities such as polymers and degradation products can enhance immunogenicity.
Formulation and Packaging: Excipients, storage conditions, and packaging materials can influence immunogenicity.
3. Treatment-related factors:
Route and frequency of administration: For example, intradermal or inhalation routes are more likely to elicit immune responses than intravenous or oral administration; repeated continuous dosing is more likely to induce immune responses than single-dose administration.
4. Patient-related factors:
Immune system status: In patients with autoimmune diseases, the immune system is typically in a state of activation, making them more prone to mounting immune responses.
Potential risks of immunogenicity:
1. Development of anti-drug antibodies (ADA):
Neutralizing antibodies: They block the binding of drugs to their targets, thereby reducing therapeutic efficacy.
Non-neutralizing antibodies: Although they do not directly neutralize the drug’s activity, they can form immune complexes that accelerate drug clearance or trigger adverse reactions.
2. Reduced efficacy:
The formation of ADA may reduce or eliminate the original therapeutic efficacy of the drug.
3. Security Issues:
Immune complexes can give rise to adverse effects associated with antigen–antibody complexes, such as allergic reactions.
4. Accelerated drug clearance:
Immune responses may lead to the rapid clearance of drugs and their metabolites, thereby shortening the drug’s half-life.
Immunogenicity is a complex, multifactorial biological process, and its assessment and control are critical for drug development and clinical application, effectively mitigating treatment failure and safety risks.
Hycells Macromolecular Immunogenicity Platform
Drawing on a PBMC sample bank comprising over 1,000 Chinese and international cohorts, Hycells, in collaboration with Weixin Computing, leverages the company’s next-generation AI-driven drug design and computational platform, WeMol, to efficiently assess drug immunogenicity risk through a dual strategy of AI prediction combined with in vitro experimental validation.
1. AI Prediction Results
L: Low risk, ADA ≤ 5%; M: Moderate risk, ADA 5–20%; H: High risk, ADA ≥ 20%.
2. Experimental Validation Results of the Hycells Macromolecular Immunogenicity Platform
Red: High immunogenicity Orange: Moderate immunogenicity Green: Low immunogenicity
Leveraging a rich, years-built sample bank, Hycells can provide PBMCs with specific phenotypes and offer donor pre-screening services tailored to client needs, thereby delivering more precise immune cell profiling for early-stage drug development. In addition, the company’s independently developed dendritic cell (DC) induction and differentiation medium further expands the service scope of its immunogenicity assessment platform. Through a comprehensive, end-to-end service model encompassing “sample resources, tools and reagents, and evaluation systems,” Hycells continuously helps biopharmaceutical companies enhance their R&D efficiency.
Product advantages of DC induction differentiation medium:
No monocyte depletion required; PBMC-based culture system; easy to operate.
Rapid induction in 3–7 days, shortening the experimental timeline.
DC cell recovery rates range from 30% to 70%, outperforming imported brands.
Leveraging a PBMC library for preliminary screening and validation reduces the impact of individual variability, resulting in a more stable assay system.
Domestic spot supply, stable availability.
Hycells boasts a comprehensive immunogenicity evaluation platform and quality management system, and has successfully provided immunogenicity assessment services for macromolecular drugs, nucleic acid therapeutics, and peptide-based therapies to numerous clients. Please feel free to inquire for detailed case data.
Customers who sign up for the immunogenicity validation service will receive one free immunogenicity prediction analysis on the WeMol platform (limited to one molecule per customer during the promotion period). For more details about the promotion, please contact Hycells.
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