Polyclonal Antibody Therapeutics: Analytical Innovations and Regulatory Perspectives for Addressing Heterogeneity Challenges

AI is reshaping how we characterise complex antibody therapeutics—and PolySeq.AI is part of that conversation!

We’re excited to see PolySeq.AI, BSI’s newest AI-driven solution, featured in the recent review paper, Polyclonal Antibody Therapeutics: Analytical Innovations and Regulatory Perspectives for Addressing Heterogeneity Challenges.

As Kumar et al. highlight, continued progress in the characterisation of complex biological products depends not only on advances in analytical workflows and instrumentation, but also on the ability to extract meaningful insight from the increasingly large and complex datasets they generate. There is a growing need for specialised algorithms and tools capable of handling the scale and heterogeneity of modern mass spectrometric data.

In particular, the review cites our work on PolySeq.AI, describing how it was applied to bottom‑up proteomic analyses for de novo sequencing of antibody mixtures. PolySeq.AI is an automated, AI‑driven platform that enables full de novo sequencing of complex polyclonal antibodies by integrating intact mass, middle‑down, and bottom‑up mass spectrometry—without relying on external databases. It achieves >99% sequencing accuracy, making antibody characterisation fast, reproducible, and practical at scale.

While positioned as a proof of concept, the authors emphasise that this study: “highlights the transformative potential of AI‑based tools to enable sequence‑level characterization of pAb products.” We’re proud to see PolySeq.AI recognised in this important discussion and to contribute to the evolving analytical toolbox needed to address the unique challenges of polyclonal antibody therapeutics.

Reach out to discover how our AI‑driven solutions can take your data analysis even further!

Read the review: Kumar, S., Tini, A., Tengattini, S., Rinaldi, F., Calleri, E., Massolini, G., & Temporini, C. (2026). Polyclonal Antibody Therapeutics: Analytical Innovations and Regulatory Perspectives for Addressing Heterogeneity Challenges. Analytical Chemistry. doi:10.1021/acs.analchem.5c06531

Read on PolySeq.AI: Sequencing of Polyclonal Antibodies by Integrating Intact Mass, Middle–Down, and De Novo Bottom–Up Mass Spectrometry