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ADC Product Characterization

ADC product characterization, testing, and assays for biotherapy development

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

Related Product Resources

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

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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)

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 Services
Early Development Product Characterization
Whether you are testing cell pools or isolated clones, we have compliant mAb-based assays to suit the level of characterization you require to understand the function and critical quality attributes of your biotherapy.
Interlot & Biosimilar Comparability
If your mAb is an original product or a biosimilar, our comparability studies ensure robust and reproducible mAb production while establishing comparability between different production facilities or between biosimilars and original products.
Lot Release & Stability
If your mAb is an original product or a biosimilar, our comparability studies ensure robust and reproducible mAb production while establishing comparability between different production facilities or between biosimilars and original products.
Process & Product Impurities
Combining experience, state-of-the-art instrumentation, and fast turnaround times, we provide reliable assays that help control process and product impurities in mAb biologics and push your project forward.

Related Videos

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Biotherapy Characterization: Cell-Based Assays
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
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
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
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.
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