“Aptamers as quality control tool for production, storage and biosimilarity of the anti-CD20 biopharmaceutical rituximab”
Sabrina Wildner, Sara Huber, Christof Regl, Christian G. Huber, Urs Lohrig and Gabriele Gadermaier
Abstract:
Detailed analysis of biopharmaceuticals is crucial for safety, efficacy and stability. Aptamers, which are folded, single-stranded oligonucleotides, can be used as surrogate antibodies to detect subtle conformational changes. We aimed to generate and assess DNA aptamers against the therapeutic anti CD20 antibody rituximab. Six rituximab-specific aptamers were obtained using the magnetic bead-based systematic evolution of ligands by exponential enrichment (SELEX) technology. Five aptamers showed exclusive specificity to the Fab fragment of rituximab while one aptamer revealed a broader recognition pattern to other monoclonal antibodies. Structural differences upon incubation at 40 °C for 72 h or UV exposure of rituximab were uncovered by four aptamers. High similarity between rituximab originator and biosimilar lots was demonstrated. For the first time, a panel of rituximab-specific aptamers was generated allowing the assessment of conformational coherence during production, storage, and biosimilarity of different products.

The open access article can be found  here.

Reviewed by Fritz Aberger

CONGRATULATIONS!