Comprehensive Analytics For Biologics & Bioconjugates

Analytics play a critical role in characterizing a molecule’s biophysical properties and evaluating its overall manufacturability, key factors in ensuring the target product profile (TPP) can be successfully achieved in the clinic. However, developing robust analytical methods during the preclinical phase presents unique challenges. With limited knowledge of a therapeutic’s attributes and evolving regulatory expectations, developers must carefully balance speed with data quality.

Variations in sequence, post-translational modifications (PTMs), higher-order structure, and conjugation chemistry can introduce serious liabilities, including aggregation, fragmentation, oxidation, deamidation, or isomerization, and glycoform heterogeneity. Left undetected, these issues can compromise safety, efficacy, and manufacturability. The lack of early analytical insight can lead to late-stage development setbacks, delaying IND submissions by months and resulting in costly rework.

At Abzena, we mitigate these risks by developing, executing, and documenting phase-appropriate analytical methods that generate high-quality, well-characterized material and the data needed to support both R&D and regulatory submissions. Our expertise ensures alignment with global regulatory standards, including those of the FDA, EMA, and PMDA. By delivering rapid, reliable analytical data at each development stage, we help accelerate and de-risk your biologic’s journey to the clinic and ultimately, commercialization.