Structural and physicochemical characterization is a core component of biologics quality science. Our characterization platform—equipped with industry-leading instrumentation and staffed by experienced large-molecule analysts—focuses on structural and physicochemical studies across diverse modalities. Through multi-project experience, ongoing technological development, and continuous hardware/software upgrades and compliance training, we provide a comprehensive characterization solution that efficiently supports quality studies at all development stages and ensures timely project delivery.

We perform structural and physicochemical studies for a wide range of modalities — mAbs, bispecifics, fusion proteins, vaccines, PEGylated proteins and ADCs (various conjugation chemistries). Our work has supported numerous INDs and late-stage comparability assessments.

Stage-appropriate services include: including early-stage druggability assessment, developability evaluation, CMC support, drug-substance characterization, stability studies, comparability/similarity studies and release testing.

Beyond routine characterization, our platform enables advanced quality research, including: