Newsletter | December 7, 2021

12.07.21 -- Mitigating Risks And Expediting Biologics Development

 
Cell-Based Potency Assay In Functional Characterization Of Therapeutic mAbs
 

Characterization of an originator monoclonal antibody (mAb), or a comparability study between originator mAbs and biosimilar candidate mAbs, is challenging, due to the highly complex and variable structure of monoclonal antibodies. Learn the crucial role cell-based potency assays play in this process.

Evaluating Viral Clearance For Continuous Processes
 

Is viral clearance a hurdle to implementing continuous processing? We share virus spiking alternatives that may pave the way for effectively evaluating viral clearance by chromatography steps in a continuous process.

Similar Enough Product Characterization To Support Process Changes And Biosimilar Development
 

Small differences in manufacturing conditions can have dramatic effects on a product’s structure and biological activity. Characterization is essential to understand the impact following process changes and successful biosimilar development. Learn the best approaches for comparability studies.

The Butterfly Effect: The Impact Of Small Changes To Your ADC
 

In this webinar, explore the influence of various PEG linkers on the structure of a model ADC by identifying specific sites of conjugation by peptide mapping, investigating changes in higher order structure by HDX mass spectrometry, and examining the impact on binding by SPR spectroscopy.

The Effect Of Discreet PEG Linkers On ADC Structure And Binding
 

For an ADC, the choice of the linker can have a dramatic effect on both physical structure and biological activity. The increased hydrophilicity provided by a PEG linker can influence the potency, toxicity and pharmacokinetics of the ADC. This example demonstrates the importance of an appropriate linker and the need for thorough product characterization to understand the structure-function relationships of an ADC.

Solutions
BioReliance Testing Services

Choosing the right partner for analytical and bioanalytical services is critical in the approval race. We offer a full suite of services and risk-mitigating approaches designed to help you bring life-changing drugs to market, faster. Learn more about our cell banking and testing, raw materials testing, lot release testing, clearance validation, virus manufacturing, genetic toxicology, and product characterization.

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