By developing your antibody drug conjugate (ADC), you’re helping advance medical treatment in revolutionary ways. These novel biotherapies that link monoclonal antibodies to deliver highly potent active pharmaceutical ingredients (HPAPIs) are inherently complex, but they can be very effective for targeting unhealthy cells. To ensure the safety and effectiveness of your ADC, it’s imperative to characterize your biotherapy to confirm its structure, binding, purity, and potency.

Partner with us to get expert guidance on the biological components of your ADC, both the ‘naked’ antibody and
the drug-conjugated antibody. We work with you to de-risk the development and manufacturing process by providing
safer, reliable, and faster testing, expediting product quality decisions at critical junctures.

You’ll have access to: GMP compliant laboratories Up-to-date regulatory advice and oversight Cutting-edge technology and equipment Experienced scientists and a dedicated project management team

Resources: Understanding the Effect of Discreet PEG Linkers on ADC Structure and Binding Download Poster White Paper Title: Not Everyone Loves Surprises: Know your ADC’s Critical Quality Attributes Download White Paper

The primary mechanism of action (MoA) for ADCs is direct cytotoxicity through intracellular release of a toxin following specific binding to target tumor antigen. However, understanding the role of the antibody in directing an ADC to tumor cells and the potential for immune recruitment as a secondary contributing MoA reinforces the importance of understanding:

• 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

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
	HDX-MS
	Differential Scanning Calorimetry
	Circular Dichroism
	Purity
	Free Chemical Related Impurities
	Residual Drug
	CE-SDS (Reduced & Non-Reduced)
	Capillary isoelectric focussing (cIEF)
	Size-Exclusion Chromatography
	Dynamic Light Scattering (DLS)
Binding	ELISA (Target binding)
	Flow Cytometry (Target binding)
	SPR (Target binding and affinity)
	SPR (Fcgamma 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)

Hear from Our Experts Get insight into topics that directly impact your success to clinic. Learn more from our white papers, videos, webinars, and posters. Knowledge Center

Contact Us Contact our product characterization experts to discuss your specialized needs and take the next step to securing the future of your biotherapy. Ask Us a Question Connect with Us on LinkedIn