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.
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
The intrinsic complexity of developing and manufacturing ADCs creates major challenges when trying to bring these life-saving therapies to market. Combatting many of these obstacles requires robust product characterization throughout all phases of development.
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.
Understanding the Effect of Discreet PEG Linkers on ADC Structure and Binding
To investigate the chemical challenges that can be overcome by the right choice of the linker, we have explored the influence of a variety of PEG linkers on the structure of a model cysteine-bioconjugate.
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.
Process Impurities: Don't Let PEI or HCP Derail your Biotherapy
We review strategies within product characterization to effectively detect and characterize host cell proteins (a factor in mAb therapies and cell and gene therapies), and polyethylenimine (PEI), used in cell and gene therapy products.
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.
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.