Investigation of Antibody Fab Region Stability for Enhancing Biopharmaceutical Development Using DSC
Thermal Stability Evaluation Device: Differential Scanning Calorimeter
MicroCal DSC Application Note “Investigation of Antibody Fab Region Stability for Enhancing Biopharmaceutical Development Using DSC”
This application note examines the domain-by-domain unfolding characteristics of 17 human or humanized IgG1 and IgG4 antibodies using DSC. This includes Tysabri™, which has been clinically demonstrated for treating multiple sclerosis, seven molecules undergoing Phase I or II trials, four molecules approved by the FDA as Investigational New Drugs (IND) in 2007, and six molecules under research. This dataset can be used as an antibody development reference guide for researchers involved in antibody drug discovery to understand whether thermal stability might pose a challenge for a given antibody.
In the second part, the process of providing stability to particularly unstable antibodies is described. The combination of stabilizing mutations resulted in a Fab Tm value of 92°C as measured by DSC. Stabilization showed significant improvement in functional expression of the antibody fragments in E. coli.
(A) DSC data of four human or humanized IgG1 antibodies (BIIB16, BIIB6, BIIB4, BIIB1)
(B) DSC data of IgG1 and IgG4 BIIB7 antibody
Reproduced with permission from Elsevier (1)
(B) DSC data of IgG1 and IgG4 BIIB7 antibody
Reproduced with permission from Elsevier (1)
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