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Biologics Characterization
Protein identity, purity, potency, and structural characterization for monoclonal antibodies, peptide therapeutics, and recombinant proteins.
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Biopharma Analytical Services:
GMP-Ready Testing & Documentation
Regulatory-grade analytical testing for biologics, ADCs, biosimilars, and complex drug products. IND/BLA-ready data packages. GLP-compliant. CoA with every report.
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Injectable Release Testing
USP <71> sterility, LAL endotoxin (BET), particulate matter (USP <787>), and container closure integrity testing for injectable biologics.
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IND/BLA Data Packages
Complete analytical data packages aligned with FDA/EMA requirements for IND applications, drug master files, and BLA submissions.
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Our scientists work with your team to design the right analytical program from day one.