Recombinant Proteins & Monoclonal Antibodies

We offer a wide range of services to support recombinant proteins and monoclonal antibodies throughout the development life cycle. Our capabilities include biosafety testing such as cell line characterization and virus testing, alongside characterization, purity analysis, potency testing and stability studies.

For monoclonal antibodies specifically, we support analytical and functional testing including aggregation analysis, binding assays, cell-based bioassays and comparability studies. Additional services include formulation development, stability programs and GMP quality control testing for raw materials, drug substances and finished products. 

We support recombinant protein and monoclonal antibody programs from early-stage research through clinical trials and commercial release. Advanced analytical technologies help identify critical quality attributes and support regulatory requirements for biologic therapies.

Bioanalytical services support both preclinical and clinical studies, while method development and validation services ensure assays remain robust and reproducible as programs progress. GMP quality control testing then provides continued assurance through clinical and commercial supply.

Our bioanalytical services support both preclinical and clinical studies, including pharmacokinetic (PK), pharmacodynamic (PD), immunogenicity and biomarker testing. These services help generate reliable data for regulatory submissions and clinical development programs.

For monoclonal antibodies, we support a variety of analytical and functional testing needs, including aggregation analysis, binding assays, cell-based bioassays and comparability studies. These services support process changes and biosimilar development as well as standard development programs.

Yes. Our method development and validation services are tailored specifically for complex biologics and aligned to global regulatory standards, including GLP, GMP and GCP requirements. This supports the generation of robust, compliant data for biologics programs.

We provide GMP quality control testing for raw materials, drug substances and finished products. This is complemented by formulation development, stability programs, characterization and purity analysis to support consistent product quality from development through commercial release.