Analytical Services for mAb, ADC, and Protein Drugs

Analytical and bioanalytical methods are crucial in the development of monoclonal antibodies (mAb), antibody-drug conjugates (ADC), and other protein drugs. From early-stage discovery and preclinical testing to clinical trials and CMC (Chemistry, Manufacturing, and Controls) support, robust analytical methodologies ensure the safety, efficacy, and quality of therapeutics. Their role is indispensable in advancing innovative therapies and bringing life-saving treatments to patients.

Our Expertise

We are dedicated to accelerating your biologic drug development process and ensuring the safety, efficacy, and quality of your therapeutic candidates. Our expertise spans genomics, proteomics, microbial analysis, and immunoassays, supporting a wide range of biologics, including monoclonal antibodies (mAbs), Antibody-drug conjugates, protein drugs, and other therapeutic proteins. Explore our detailed service offerings below, categorized into preclinical studies, clinical studies, and Chemistry, Manufacturing, and Controls (CMC)

Analytical Support Through All Stages of Product Lifecycle

Phase

Technologies

Applications

Development

qPCR, ddPCR, Sanger Sequencing, NGS, Flow Cytometry, ELISA, MSD, LC/MS/MS, Western Blot, Cell-Based Assays

Cell line development support
Clone selection/screening
Genetic stability testing
Growth kinetics analysis
mAb /Protein Expression and Characterization

Preclinical Studies

qPCR, ddPCR, Flow Cytometry, ELISA, MSD, LC/MS/MS

Preclinical PK/PD studies
Immunogenicity studies
Biomarker analysis
In vitro efficacy studies
Cytokine release assays

Clinical Studies

qPCR, ddPCR, Sanger, NGS, Flow Cytometry, ELISA, MSD, LC/MS/MS

Clinical PK/PD studies
patient stratification
Immunogenicity testing
Biomarker validation
Companion diagnostics development
Cytokine release assays

CMC Support

qPCR, ddPCR, Sanger, NGS, Flow Cytometry, ELISA, MSD, LC/MS

Identity assays
Stability Testing
Potency Assays
Batch consistency
Product characterization
Impurity profiling
Compendial assays

Have Questions?

Partner with us for comprehensive analytical support to advance your biologic drug development efforts. To learn more about our services or to discuss your project needs, please contact us.