Bioanalysis &
Immunogenicity
GLP-certified bioanalysis for preclinical and clinical studies of biologics and biosimilars, including immunogenicity assessment.
Comprehensive Bioanalysis of Biological Drugs
BrownBiology Laboratory offers bioanalytical services for a wide range of biological drugs from preclinical and clinical studies, including innovative proteins, biosimilars, therapeutic peptides and enzymes, biomarkers, monoclonal antibodies, hormones, nucleic acids and other large molecules.
We are a GLP-certified and GCP-compliant multinational CRO with broad experience in method transfer, regulatory validations and the development of challenging bioanalytical methods for biological drugs from scratch. Our state-of-the-art analytical tools include ELISA, ECLA, HPLC-MS/MS tryptic digestion, and routine work covers drug levels, PK/PD calculations, and immunogenicity assays including ADA binding and neutralizing antibodies.
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Our Services
BrownBiology Laboratory provides end-to-end bioanalytical support for biologics and biosimilars across preclinical, clinical, and immunogenicity study phases.
Preclinical Studies of Biologics & Biosimilars
- PK (pharmacokinetics) levels
- PK and PD (pharmacodynamic) calculations and statistics
- Metabolite identification and quantitation
- Toxicokinetics of biological drugs
- Biomarkers / Pharmacodynamics
Clinical Studies of Biologics & Biosimilars
- PK (pharmacokinetics) levels
- Phase I鈥揑V pharmacokinetics including first-in-man dose escalation studies
- Metabolite identification and quantitation
- Biological drug鈥揹rug interaction studies
- Biomarkers / Pharmacodynamics
Immunogenicity Assays
- Determination of Binding Anti-Drug Antibodies (ADA)
- Determination of Neutralizing Anti-Drug Antibodies (NAb)
- Screening, Confirmatory, Titration, and Isotyping assays
- Cell-based assays (CBA) and binding assays
- SPR (Biacore庐), ELISA, and ECLA platforms
Analytical Platforms
Our bioanalytical service for biological drugs relies on multiple state-of-the-art immunological and mass spectrometry techniques, enabling comprehensive coverage for any project requirement.
ELISA
Direct, sandwich, bridge, or competitive formats with colorimetric, fluorescence, and time-resolved fluorescence detection.
ECLA (MSD庐)
Electrochemiluminescence by high-throughput Meso Scale Discovery for enhanced sensitivity.
HPLC-MS/MS
Tryptic digestion of proteins and signature peptide quantification for large molecule analysis.
SPR (Biacore庐)
Surface Plasmon Resonance for real-time, label-free binding analysis of ADA and NAb.
UV-Vis Activity
Enzyme activity quantification through spectrophotometric methods.
Real-Time qPCR
RTqPCR for sensitive nucleic acid quantification in biological matrices.
Immunogenicity Services
Novel biological drugs have the potential to induce immune responses which can impact pharmacokinetics, efficacy, safety, and cross-react with endogenous molecules. BrownBiology Laboratory offers comprehensive immunogenicity assessment services:
Anti-Drug Antibody (ADA) Detection
- 鈥?/span>Screening assays for positive sample detection
- 鈥?/span>Confirmatory assays to rule out false positives
- 鈥?/span>Titration assays for immuno response quantification
- 鈥?/span>Isotyping assays to identify ADA isotypes
Neutralizing Antibody (NAb) Determination
- 鈥?/span>Cell-based assays (CBA)
- 鈥?/span>Binding assays via ELISA, ECLA, or SPR (Biacore庐)
Full-Service Assay Development
Including production of antibodies for ligand binding assays and labeled reagents.
Why Choose BrownBiology?
Regulatory Excellence
FDA and EMA inspected, GLP-certified, and fully compliant with ICH M10 and EMA guidelines on therapeutic protein pharmacokinetics.
Global Trust
Preferred partner to multiple innovators for biological drugs and biosimilar developers worldwide.
Extensive Expertise
Proven experience developing, validating, and transferring methods for complex large molecules, integrating mass spec and immunogenicity services.
State-of-the-Art
Equipped with ELISA, ECLA (MSD庐), SPR, HPLC-MS/MS, Real Time qPCR, and LC-MS/MS platforms.
Ready to advance your biologics program?
Let our experts design the optimal bioanalytical strategy for your biological drug or biosimilar development.