Comprehensive Analytical Services for Biologics & Bioconjugates

Analytics are central to defining a molecule’s biophysical profile and manufacturability, ensuring the target product profile (TPP) can be achieved in the clinic. Yet, in early development—when material is scarce and regulatory guidance is evolving—robust methods must strike a balance between speed and uncompromising data quality.

Abzena designs, executes, and documents phase-appropriate assays that are qualified or validated to ICH Q2(R1/R2) and ICH Q14, generating high-quality, well-characterized material and submission-ready data packages for FDA, EMA, and PMDA filings. By delivering rapid, decision-enabling analytics at every stage, we shorten and de-risk the path from discovery to first-in-human studies and beyond.

Our integrated analytics platform—backed by 20+ years of experience—couples orthogonal, high-throughput techniques (LC-MS/MS, CE-SDS, SEC-MALS, thermal ramping, and more) with global, multi-site capacity. From early screening through GMP release, we provide the data, documentation, and regulatory support your biologic or bioconjugate needs to advance with confidence.

Download the “Comprehensive Analytics for Biologics & Bioconjugates” info sheet to learn how Abzena’s expertise can keep your program moving forward.