ADC Product Characterization

Antibody drug conjugates (ADCs) that link monoclonal antibodies to deliver highly potent active pharmaceutical ingredients (HPAPIs) are inherently complex, making it imperative that you characterize your biotherapy to confirm its structure, binding, purity, and potency. As your characterization partner, we can provide expert guidance on the biological components of your ADC in both its “naked” and drug-conjugated versions – conducting safer, more reliable, and faster testing that helps to expedite product quality decisions at critical junctures.

Our ADC product characterization services feature: 

• GMP compliant laboratories
• Up-to-date regulatory advice and oversight
• Cutting-edge technology and equipment
• Experienced scientists and a dedicated project management team

Request Information

Related Resources

Webinar: Learn How Molecular Structure Influences Potency of a Therapeutic Biologic
Webinar: Process Impurities: Don't Let PEI or HCP Derail your Biotherapy
Millipore^® CTDMO Services

Assays that de-risk development and manufacturing

The safety and effectiveness of your ADC starts with understanding the role played by the antibody in directing an ADC to tumor cells, as well as the potential for immune recruitment. Our broad range of assays for conjugated and unconjugated forms can help identify a variety of critical factors:

• Antibody structure–function relationship
• Desired quality attributes for its chosen application
• Binding to the target antigen
• Cytotoxic activity
• Impact on efficacy following conjugation
• Functionality following conjugation
• Choice of linker used or the method of conjugation

See standard assay recommendations that can reveal your ADC’s structure, binding, and potency.

Structure (Identity)

Primary structure Molecular Weight (intact, reduced, deglycosylated) by LC-MS Peptide Map by LC-MS or LC-MS/MS Disulfide Map by LC-MS Site of Conjugation by LC-MS/MS DAR (Drug-Antibody Ratio) by HIC-HPLC, UV or LC-MS Non-Conjugated Form (D0) by LC-UV N-Glycan Profile by LC or LC-MS Higher order structure

Differential Scanning Calorimetry Circular Dichroism Purity Free Chemical Related Impurities Residual Drug CE-SDS (Reduced & Non-Reduced) Capillary Isoelectric Focusing (cIEF) Size-Exclusion Chromatography Dynamic Light Scattering (DLS)

Binding

ELISA (Target binding) Select any characteristic below Flow Cytometry (Target binding) SPR (Target binding and affinity) SPR (Fc gamma receptor binding and affinity) SPR (FcRn binding and affinity)

Potency

Biological Activity Cytotoxicity Assay ADCC -Primary Cell or Reporter CDC ADCP -Primary Cell or Reporter Internalization Assay

Compendial

pH Osmolality Concentration Appearance Packaging Integrity Karl Fischer Moisture Analysis Dye Ingress (Confirm Closure Integrity)

An adaptive partner with specialist expertise

To help you bring safe new treatments to market, Merck’s BioReliance^® Testing Services offers a broad portfolio of biotherapy characterization, safety testing, and process development, through every step of development, from drug discovery to market approval. Our experienced teams paired with our operational expertise and deep regulatory understanding help you minimize risk at every step of your process.

Related Videos

Slide 1 of 4

Biotherapy Characterization: Cell-Based Assays

Senior Scientist, Agata Burzawa, MSc, describes how designing cell-based assays to help our clients understand the complex biological functions of the therapy they are developing as a part of product characterization.

Biotherapy Characterization: Binding Assays

Senior Scientist Helen Hsu, Ph.D. describes how, with our custom binding assays, and supported with our comprehensive off-the-shelf Fc gamma receptor binding assays, we can help you optimize your mAb production, from clone development through upstream and downstream processes.

Explore What's Next in Product Characterization

The complexities of biological manufacturing, the large size of the molecules, and the product heterogeneity introduced by cellular expression systems present significant challenges to measuring the quality of a biologic drug. Newer, high-resolution analytical techniques help answer questions regarding product heterogeneity and drug functions, and help assess for product-related aggregates and impurities.

Understanding Cytokine Activation

Product Characterization Scientist, Rachel Wood, introduces the multiplexed cytokine release assay. A highly sensitive assay that requires low sample volumes to measure the cytokine release activity induced by your mAb.