U.S. Biologics, Advanced Therapies & Medical Devices Manufacturing and Testing

protein characterization

Utilizing laboratories in China and the U.S., WuXi AppTec provides a comprehensive range of analytical development and testing services to characterize biological therapeutics. Whether evaluating production lots to a reference standard or performing comparability studies of biosimilars or biobetters, WuXi AppTec has the full-range of product characterization assays available to provide the detailed analysis required to pass scientific and worldwide regulatory standards.

The service scope covers both standalone analytical projects as well as analytical support for integrated process and product R&D projects. Our testing services provide high-quality analysis required throughout discovery, development, clinical trials, and commercialization. Assays can be transferred, developed, verified, qualified or validated, and can be run under R&D, GLP or GMP conditions. Professional and strict documentation and management systems have been developed to efficiently support all the projects.

A battery of regulatory-compliant tests needed to characterize your product or reference standard are available, including methods for determination of molecular weight, peptide mapping, amino acid N- and C-terminal sequencing, glycan composition analysis, and extinction coefficient determinations. See the table below for a more comprehensive listing of assays.

mAb Release Tests Purity – Appearance
– Protein concentration
– Sub-visible particle
– Aggregates and fragment (HP-SEC)
– Charge variants (HP-IEX)
Identity – Peptide mapping
– CEX-HPLC
– Immunoassay
Safety – Sterility
– Bacterial endotoxin
– Host Cell Protein (HCP) ELISA
– Protein-A ELISA
– Residual DNA
– Leachable
Potency – Binding assay
– Functional assay
mAb Characterization Tests Primary
Structure and
PTMs
– Intact / Reduced Mass Analysis
– Peptide Mapping by LC-MS
– Glycosylation Profiling
– Disulfide Mapping
– N- / C- terminal Verification
Functional – Antigen binding