PK/PD Bioanalysis and Immunogenicity Assessment for Biologic Products
We design and perform comprehensive PK bioanalysis and immunogenicity studies for monoclonal antibodies, therapeutic proteins, and biosimilars, aligned with regulatory requirements and the specific needs of each development phase.
- PK/PD studies
- Immunogenicity (ADA and NAb)
- Method development and validation
- Regulatory support
Our service integrates quantification of biologics in complex matrices, evaluation of immune response, and analytical development tailored to each program, using technologies such as ELISA, LC-MS/MS, and cell-based assays.
From study and method design through to analysis and final reporting, our approach is focused on generating robust data applicable to preclinical, clinical, and biosimilarity studies.
We provide an integrated bioanalytical perspective to support clinical and regulatory decision-making, combining method development and validation, expertise in complex molecules, and integration with complementary techniques according to the needs of each program.
What is PK Bioanalysis and Immunogenicity Assessment?
PK (pharmacokinetic) bioanalysis measures the concentration of a drug in biological matrices (plasma, serum, etc.) to understand its absorption, distribution, metabolism, and elimination.
Immunogenicity assessment evaluates the immune system response to a biologic, identifying antibodies that may affect its efficacy or safety.
Main Applications of PK Bioanalysis and Immunogenicity Assessment for Biologics
- Preclinical and clinical pharmacokinetic studies (Phases I–III)
- Bioequivalence and biosimilar studies
- Therapeutic monitoring of biologics
- PK/PD correlation studies
- Immunogenicity studies in clinical development
- Assessment of impact on efficacy and safety
What Does Our Service Include?
1. PK Bioanalysis of Biologics and Peptides
LC-MS/MS PK Assay
Highly sensitive and specific quantification of therapeutic peptides and smaller proteins by LC-MS/MS using isotopically labelled internal standards. Key advantages include:
- High sensitivity and selectivity
- Accuracy in complex matrices
- Analytical robustness
Quantitative ELISA for Biologic Drugs (PK)
Sandwich or ligand-binding immunoassays for quantification of monoclonal antibodies and other biologics in human and animal matrices. Applications include:
- PK studies in clinical phases
- Therapeutic monitoring
- Biosimilar development
2. Immunogenicity Assessment: ADA and NAb
Anti-Drug Antibodies (ADA)
ADA detection using bridging ELISA assays in compliance with European Medicines Agency and U.S. Food and Drug Administration recommendations, including:
- Screening
- Confirmation
- Titration
Neutralizing Antibodies (NAb)
Competitive functional assays that evaluate the ability of antibodies to inhibit the drug–target interaction. These assays allow:
- Characterization of immune response
- Evaluation of impact on pharmacological activity
- Support for benefit-risk decisions
Technologies and Methodologies Used
- LC-MS/MS (liquid chromatography coupled to mass spectrometry)
- ELISA (Enzyme-Linked Immunosorbent Assay)
- Ligand-binding assays
- Competitive functional assays
ELISA is an immunoanalytical technique based on the specific antigen–antibody interaction, widely used for sensitive and selective quantification of proteins in complex matrices.
Regulatory Compliance
To ensure data reliability for regulatory and clinical studies, our assays are developed and validated in accordance with:
- European Medicines Agency
- U.S. Food and Drug Administration
- International Council for Harmonisation
Frequently Asked Questions (FAQ)
- What types of samples can be analysed?: Mainly plasma and serum, although methods can also be adapted to other biological matrices.
- What is the difference between ADA and NAb?: ADA detect the presence of antibodies against the drug, while NAb assess whether those antibodies affect its biological function.
- Which regulations must these studies comply with?: Assays should align with European Medicines Agency (EMA), U.S. Food and Drug Administration, and International Council for Harmonisation guidelines, especially for clinical and regulatory studies.
- Can specific methods be developed for my product?: Yes, Netpharmalab develops and validates customised bioanalytical methods according to the characteristics of each biologic.
- At which development stages are these studies performed?: From preclinical phases to clinical trials (Phases I–III) and post-marketing studies.
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