Quality Control of
Biologics & Biosimilars
GMP-certified quality control for advanced biological therapeutics, ensuring structural integrity and functional potency across the entire product lifecycle.
Expert Biopharmaceutical Analysis
BrownBiology Laboratory provides high-end GMP-certified quality control services for biological drug substances and products, including monoclonal antibodies, recombinant proteins, and biosimilars.
Our specialized laboratories are equipped with the latest technology for capillary electrophoresis, high-resolution mass spectrometry, and biological assays to ensure your molecules meet the strictest regulatory requirements (EP, USP, BP, JP).
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Our Capacities & Technologies
Comprehensive analytical solutions for characterization, purity testing, and potency validation.
1Identity Confirmation
- Amino acid analysis & Quantitation
- Extinction coefficient determination
- Peptide mapping (reduced & non-reduced)
- Glycan profiling & Monosaccharide analysis
2Purity & Heterogeneity
- Capillary Electrophoresis (CE-SDS, cIEF)
- Size-Exclusion HPLC (SE-HPLC)
- Ion-Exchange HPLC (IE-HPLC)
- Reversed-Phase HPLC (RP-HPLC)
3Potency & Binding
- ELISA-based binding assays
- Cell-based functional assays
- Surface Plasmon Resonance (SPR)
- Target-specific bioactivity tests
4Residuals & Contaminants
- Host Cell Proteins (HCP)
- Residual Host Cell DNA (qPCR)
- Protein A residuals
- Mycoplasma & Sterility (Microbiology)
Batch Testing & Global Release
BrownBiology Laboratory supports global manufacturers with GMP-certified importation, testing, and QP batch release. We handle sterile products, high-potency molecules, and complex biologics with absolute precision.