Analytical characterization is at the heart of biologics development. Whether it’s confirming molecular structure, monitoring product quality, or understanding stability over time, every data point tells a story about how a biologic behaves. At Bora Biologics, we see analytical science as both a discipline and a mindset—one that evolves with technology, regulatory expectations, and the growing complexity of therapeutic modalities.

Our approach begins with the foundational assays that anchor early development. Techniques such as ELISA, HPLC, and charge variant analysis (CEX‑HPLC, iCIEF, rCE‑SDS) are more than routine tests—they establish identity, purity, potency, and comparability for global filings. Through fit‑for‑purpose assay design and cross‑platform qualification, these classical methods build early analytical confidence while supporting rapid progression toward IND and IMPD submissions.

As molecules advance into more complex formats—bispecifics, fusion proteins, ADCs, enzymes—the analytical landscape must expand. Traditional assays alone cannot resolve the full spectrum of molecular heterogeneity. That’s why our toolbox includes mass spectrometry (LC–MS/MS), capillary electrophoresis, high‑resolution chromatography, MOA‑based cell assays, and platform Fc characterization. By integrating these advanced analytics early in development, we uncover deeper molecular detail, accelerate method refinement, and reduce downstream rework.

Our teams also leverage standardized workflows and early LC‑MS integration to deliver faster, clearer, and more consistent data. This efficiency not only shortens timelines but strengthens analytical certainty—ensuring every decision is rooted in robust evidence. Scientific rigor builds regulatory confidence, and regulatory confidence accelerates development.

Looking ahead, computational and in silico analytics represent the next frontier of biologics characterization. We are exploring AI‑enabled tools for PTM prediction, stability risk assessment (aggregation, fragmentation), glycosylation modeling, and 3D structural analysis. These digital insights allow us to identify risks earlier, design more resilient assays, and generate data narratives that support sound regulatory strategy.

Ultimately, analytical science at Bora Biologics isn’t just about running tests—it’s about building understanding. We focus on transforming data into actionable insight, aligning every study with both regulatory expectations and client goals. Our culture is rooted in collaboration, precision, and transparency, ensuring that every molecule we support is characterized with scientific rigor and a clear path forward.

Because every biologic moving one step closer to patients deserves a development strategy built on clarity, confidence, and exceptional analytical science—and that begins with a toolbox designed for the future.

About the Authors

Enid Chen is a Senior Supervisor in Analytical Development at Bora Biologics, where she has been supporting biologics programs since 2015. She is an analytical development professional with deep experience guiding multiple programs through robust, phase‑appropriate analytical strategies aligned with global regulatory expectations. Enid works closely with CMC and cross‑functional teams to design and execute analytical testing frameworks that enable process development, method transfer, analytical comparability, and regulatory submissions. She holds a Ph.D. in Chemical Engineering and brings a disciplined, systems‑level approach to building analytical packages that support confident decision‑making across development stages.

Chloe Chien is a Senior Manager at Bora Biologics with over 10 years of experience in biologics CMC development across both biotechnology and academic settings. Since joining Bora in 2014, she has built extensive hands‑on expertise in analytical development, protein characterization, and proteomics, with a strong focus on biologics manufacturability and analytical‑driven CMC troubleshooting. Chloe is known for her cross‑functional, project‑driven mindset and her ability to translate complex analytical data into practical development solutions. She holds a Ph.D. in Biochemistry and is a certified Project Management Professional (PMP), enabling her to bridge scientific rigor with effective program execution.