A protein-stabilizing technology for enhanced antibody stability and antibody-binding profiles in a microchip array

Area of Science:

• Biotechnology
• Immunology
• Protein Chemistry

Background:

• Therapeutic antibody stability is crucial for downstream processing and storage.
• Maintaining antibody functionality and quality ensures therapeutic efficacy.
• Standardized methods are needed to assess antibody specificity and binding profiles.

Purpose of the Study:

• To evaluate a novel protein stabilizing and protecting solution (SPS).
• To assess SPS's efficacy in preserving the binding specificity and strength of Adalimumab (anti-TNF-α antibody).
• To compare SPS performance against the original formulation under stress conditions.

Main Methods:

• Utilized the UNIchip® high-density protein microarray with 384 antigenic targets.
• Generated standardized quantitative binding profiles to characterize antibody specificity.
• Tested Adalimumab formulated with SPS and the original formulation after lyophilization and storage at 40°C for six weeks.

Main Results:

• SPS-formulated Adalimumab exhibited significantly reduced off-target activity post-reconstitution.
• SPS formulation preserved antibody binding strength even after six weeks of storage at 40°C.
• UNIChip® confirmed the protein stabilizing effects of SPS by demonstrating preserved antibody functionality.

Conclusions:

• The novel SPS effectively preserves the binding specificity and strength of therapeutic antibodies like Adalimumab.
• SPS offers a significant advantage over original formulations in maintaining antibody quality during processing and storage.
• UNIChip® is a valuable tool for characterizing and confirming the stabilizing effects of solutions on antibody functionality.