Physicochemical Characterization
- Molecular Identity Confirmation
- Peptide Mapping
- Intact Mass Analysis
PharmaPrimes provides specialized analytical, bioanalytical, and clinical services supporting biosimilar development, registration, comparability assessment, quality control, and clinical evaluation.
Analytical testing of submission batches supporting biosimilar regulatory filings and comparability programs.
Testing of manufacturing batches for routine QC release and analysis of samples collected during stability programs.
Bioanalytical support for small molecules, peptides, therapeutic proteins, monoclonal antibodies, and biologics across preclinical, clinical, bioequivalence, and biosimilar programs.
Hospital-based clinical research through the PharmaPrimes Clinical Research Center located within Jordan Hospital in Amman.
Integrated clinical and bioanalytical support for BE/BA studies and pharmacokinetic evaluation.
From characterization and QC release to clinical PK and immunogenicity, our biologics team can support your biosimilar development.