Analytical Method Development For Biologics & Bioconjugates

Establishing scientifically sound, phase-appropriate analytical methods early in drug development is essential for accelerating progress, reducing risk, and meeting regulatory milestones. In the pre-clinical setting, developers often face limited data and unclear expectations from regulators, making it difficult to design methods that are both sensitive and specific.

A robust analytical strategy addresses these gaps, enabling informed decisions that minimize rework and streamline the path to toxicology studies and clinical trials. From cell line development to formulation and final product release, tailored assays play a critical role in identifying critical quality attributes, optimizing manufacturing processes, and ensuring batch-to-batch consistency. Advanced techniques such as mass spectrometry, chromatography, capillary electrophoresis, and functional binding assays provide high-resolution data that supports product characterization, process control, and regulatory compliance. Aligning early-phase methods with global standards like ICH Q14 and Q2(R2) ensures consistency and facilitates smoother transitions across development stages.

Explore how targeted analytical strategies can strengthen your therapeutic program and reduce development risk.