Multi-Attribute Methods Advance Analytics for Complex Therapeutic Development

Ganesh Bala, PhD, product specialist—Mass Spec, Agilent Technologies discussed the growing importance of advanced analytical strategies for complex biotherapeutics in an interview with BioPharm International® going into the 2026 AAPS National Biotechnology Conference, which is running May 11–14 in San Diego, Calif. In his conference presentation, “From Antibodies to Bioconjugates: Scalable Multi-Attribute Methods for Emerging Therapeutic Modalities,” Dr. Bala focused on methods and multi-attribute methods (MAMs).

According to Dr. Bala, increasing demand for precision medicine and improved therapeutic efficacy is driving the adoption of more complex therapeutic designs. Antibody-drug conjugates and related bioconjugates combine antibody targeting specificity with highly potent payloads, particularly in oncology and rare disease applications. However, these modalities also introduce greater molecular heterogeneity, including variable conjugation sites, drug-to-antibody ratios, and emerging degradation pathways, he notes.

As a result, developers require analytical approaches capable of delivering highly sensitive, site-specific, and quantitative characterization while maintaining throughput and process readiness, Dr. Bala explains.

How are MAMs improving analysis of advanced biotherapeutics?

MAMs use peptide mapping workflows to assess modifications, sequence variations, conjugation characteristics, and degradation-related changes within one analytical framework, Dr. Bala notes. He explains that peptide mapping offers detailed site-specific resolution, allowing developers to better understand structure–function relationships in bioconjugates.

“What multi-attribute methods [do] is that [they’re] primarily an LC–MS [liquid chromatography–mass spectrometry]-based peptide mapping, but [they] quantif[y] multiple critical quality attributes, such as modifications, sequence variations, [and] conjugation features in a single and rich assay format.” he says.

These approaches can also improve manufacturing oversight by generating highly comparable datasets across batches and enabling earlier detection of subtle process changes. According to Dr. Bala, this consistency is increasingly important as biopharmaceutical companies scale production and implement manufacturing modifications.

He adds that analytical technologies must evolve alongside therapeutic innovation, emphasizing that MAM platforms are transitioning from exploratory research tools into foundational components of faster development timelines, improved decision-making, and regulatory-ready quality control strategies.

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About the speaker

Ganesh Bala, PhD, Product Specialist—Mass Spec, Agilent Technologies

Dr. Bala began his career in India in generic drug development and impurity profiling. He earned a PhD in synthetic organic chemistry in the United States, focusing on small-molecule drug discovery. He later led National Institutes of Health-funded core facilities spanning proteomics, metabolomics, and bioinformatics. Transitioning to industry, he held roles at Thermo Fisher and Bruker supporting advanced analytics adoption. He now supports Agilent’s mass spectrometry users in the Bay Area, partnering with pharma and biopharma companies to optimize workflows and enable impactful analytical solutions.