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BioReliance® Product Characterization Services

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Cell Line Development Interlot & Biosimilar Comparability Lot Release & Stability Process & Product Impurities Antibody Drug Conjugates

Assay Packages: Product Characterization for Antibody Drug Conjugates

Get to Know your ADC - Structure, Binding, and Potency


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

Understanding your ADC to De-Risk Development & Manufacturing


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


Reveal your ADC’s Structure, Binding, and Potency
Standard assay recommendations (conjugated and unconjugated forms)

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)
BindingELISA (Target binding)
Flow Cytometry (Target binding)
SPR (Target binding and affinity)
SPR (Fcgamma receptor binding and affinity)
SPR (FcRn binding and affinity)
PotencyBiological Activity
Cytotoxicity Assay
ADCC -Primary Cell or Reporter
CDC
ADCP -Primary Cell or Reporter
Internalization assay
CompendialpH
Osmolality
Concentration
Appearance
Packaging Integrity
Karl Fischer Moisture Analysis
Dye Ingress (Confirm Closure Integrity)

As you progress through the development of your ADC, we can also help prepare you for clinical trials through our ADC stability program. Find out more about our Product Characterization services for ADCs.

Learn more about our ADC Contract Manufacturing Services.

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Contact our product characterization experts to discuss your specialized needs and take the next step to securing the future of your biotherapy.

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