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mAb Product Characterization

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.

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 Services
mAbs CTDMO Services
The goal of this page is to illustrate the overarching offering of the mabs(monoclonal antibody) modality within our LSS services including testing as a comprehensive CTDMO page
ADC Characterization
As your characterization partner we can provide expert guidance on the biological components of your antibody drug conjugate (ADC) – conducting safer, more reliable, and faster testing that helps to expedite product quality decisions at critical junctures.
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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