Knowledge Center

Hear from our scientific experts about how we can help you navigate the complex world of biological drug development. Get insight into topics that directly impact your success to clinic. Learn about the product characterization process, new technologies, and new applications.

White Papers

• Early Product Characterization Mitigates Risks in Biologics Development
  Read why interrogation of product attributes using high resolution tools and techniques provides answers to crucial questions early on, such as: What are the structural attributes of the drug? And, how does this drug function biologically?

• Not Everyone Loves Surprises: Know Your ADC's Critical Quality Attributes
  The intrinsic complexity of developing and manufacturing ADCs creates major challenges when trying to bring these life-saving therapies to market. Learn how Product Characterization can help you mitigate the risks.

Posters

• Development of binding assays to measure interactions between Fc regions of therapeutic monoclonal antibodies and Fc receptors using Surface Plasmon Resonance
  See how by studying the binding interaction of your mAb with Fc receptors in the early phase of drug development reveals the potential biological activity of the product in vivo.

• Relationship between structure and function: Influence of galactosylation on Fc-mediated binding and functional properties of adalimumab
  The criticality of an antibody’s glycan structure is demonstrated by evaluating its’ Fc-region mediated effector functions through the application of a highly resolving N-glycan assay, in combination with binding and cell-based assay.

Webinars

• Learn how molecular structure influences potency of a therapeutic biologic
  Our scientists, ranging in specialty from analytical to immuno-focused, give the listener an understanding of how an antibody’s molecular structure, of which there are many measurable properties that can be measured, influences its binding and affects potency of a therapeutic biologic.

• Mitigating Risks through Product Characterization
  Multiple approaches to characterizing the physico-chemical and structural attributes of therapeutic mAbs is presented with a focus on how it influences the resulting biological activity.

Videos

	Biotherapy Characterization: Cell-Based Assays Senior Scientist Agata Burzawa, MSc, explains how we can provide you with rich data sets to help you understand your complex biotherapy faster. Using limited volumes of samples for testing, our scientists employ leading technologies that integrate cytokine release monitoring with immunophenotyping of cells within the same sample.
	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.