mAb Product Characterization

Choosing the right partner for product characterization services is critical when moving your monoclonal antibody (mAb) from concept to clinic. We work with you to de-risk the development and manufacturing process, expediting product quality decisions at critical junctures.  

Pre-configured, off-the-shelf assay packages designed to speed time to actionable data

Our comprehensive program reveals the true identity of your molecule through every phase of development, ensuring your biotherapy’s safety, purity, and potency. Select from one of our mAb-based assay packages or a custom assay tailored to your biologic. You’re one partner away from bringing your biotherapy to life.

• Early Development Product Characterization
• Interlot and Biosimilar Comparability
• Lot Release and Stability 
• Process and Product Impurities

To discuss your specialized needs and take the next step in securing the future of your biotherapy, contact our product characterization experts.

An adaptive partner with specialist expertise

To help you bring safe new treatments to market, 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 Product Resources

Webinar: Mitigating Risks through Product Characterization
Webinar: Process Impurities: Don't Let PEI or HCP Derail your Biotherapy

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Related Videos

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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.