BioReliance® Product Characterization Services
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)
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.
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.
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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