Bioanalytical Solutions for Biologics and Complex Therapies
Explore bioanalytical approaches supporting pharmacokinetics and immunogenicity assessment across biologics, including method development, validation, and sample analysis.
Bioanalytical Testing for Complex Biologics and Advanced Therapies
Deliver reliable pharmacokinetic, pharmacodynamic, and immunogenicity data through scientifically driven bioanalytical testing aligned to your clinical objectives.
Generate reliable bioanalytical data across clinical development
Your pharmacokinetic (PK), phamacodynamic (PD), and immunogenicity results depend on robust bioanalytical data. When assays, workflows, and scientific strategy aren’t fully aligned, that data can meet acceptance criteria in the lab but still fall short in the clinic.
For teams balancing tight timelines, complex molecules, and regulatory expectations, the bioanalytical plan needs to be designed around the trial from day one.
To build the right approach, we start with your clinical objectives and work backwards. Our teams specialize in complex biologics, including monoclonal antibodies, antibody drug conjugates, vaccines, and cell and gene therapies, across all phases of development.
Through validated methods, fit-for-purpose assay design, and globally harmonized quality standards, we deliver PK, PD, and immunogenicity data that is consistent and reproducible, so you can move through development with data that stands up to regulatory review.
Why choose Cerba Research for your bioanalytical strategy?
Bioanalytical capabilities across every phase of clinical development
We support bioanalytical testing across all phases of development, combining method development, validation, and sample analysis to deliver reliable and reproducible results aligned to your clinical objectives.
Pharmacokinetic (PK) analysis
Understanding drug exposure is essential for evaluating safety, efficacy, and dose selection. To support this, we generate quantitative PK data across a range of therapeutic modalities, enabling informed clinical decision-making and regulatory submissions.
Capabilities include:
- Small molecule and biologics PK assays
- Ligand-binding assay platforms
- Sample analysis across clinical phases
- PK data generation and reporting
Pharmacodynamic (PD) and biomarker analysis
Linking drug exposure to biological response provides critical insight into mechanism of action and treatment effect. We apply this through PD and biomarker assays designed to evaluate target engagement and clinical response.
Capabilities include:
- PD biomarker assay development and testing
- Target engagement and pathway analysis
- Integration with broader biomarker strategies
- Data aligned to clinical endpoints
Immunogenicity assessment
Monitoring immune response to biologics is essential for understanding both safety and efficacy. To support your program, we develop and implement immunogenicity strategies to detect and characterize anti-drug antibodies and their clinical impact.
Capabilities include:
- Anti-drug antibody (ADA) screening and confirmatory assays
- Neutralizing antibody (NAb) assessments
- Tiered immunogenicity testing strategies
- Regulatory-aligned assay approaches
Bioanalytical method development and validation
Robust analytical methods are essential for generating reliable and reproducible data. We develop, optimize, and validate these methods to ensure performance is aligned to intended use and study requirements.
Capabilities include:
- Method development and optimization
- Fit-for-purpose validation
- Sensitivity and performance characterization
- Validation documentation and reporting
Supporting services for your bioanalytical strategy
Biomarkers
Design biomarker strategies that help you answer critical clinical and biological questions.
Assay development and technology transfer
Develop robust assays and transfer methods that align with your study objectives and requirements.
Genomics
Translate genomic complexity into meaningful evidence that supports your clinical development decisions.
Flow cytometry
Characterize cellular responses with flow cytometry strategies tailored to your clinical objectives.
Histopathology
Understand disease biology through integrated pathology approaches and biomarker evaluation.
Protocol development
Align your analytical strategy with study design, endpoints, and regulatory expectations.
Bioanalysis resources and insights
Overcoming Bioanalytical Challenges in Anti-Drug Antibody Detection for ADCs
Learn how tailored immunogenicity strategies support the detection and characterization of anti-drug antibodies in complex biologics such as antibody-drug conjugates.
