Analytical Success Stories
Real-world challenges resolved through precision analytical science and regulatory expertise.
Global Biopharma Client
The Challenge
Resolving unexpected particulates in a mRNA drug substance stored in LNP format.
The Solution
Multi-modal analysis using Micro-Flow Imaging (MFI) and specialized E&L screening of single-use components.
Key Result
Identified trace levels of polymer degradation; proposed manufacturing change approved by FDA.
Emerging Biotech
The Challenge
Rapid transition of a synthetic peptide from discovery to Phase I release testing.
The Solution
Compressed method development and ICH-compliant validation performed in under 8 weeks.
Key Result
Clinical trial authorization secured without analytical pushback from health authorities.
Have a Complex Analytical Challenge?
Our case history includes hundreds of complex molecules. We bring this legacy of problem-solving to every new project.
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