Cell bank characterization
Our Cell Bank Characterization services support major biopharmaceutical production platforms, including CHO, BHK, HEK293, Vero, SP2/0, E. coli, Pichia pastoris, Sf9, and Hi5 cell lines. Our testing programs are designed to meet international regulatory expectations for the qualification of Master Cell Banks (MCB) , Working Cell Banks (WCB) and end of production cell (EOPC) in accordance with ICH, FDA, WHO, and GLP requirements.
Viral clearance
- Viral Clearance and Process Validation
- Advanced FPLC System for Accurate Protein Separation
- UV, pH, Conductivity, and Fluorescence Detection
- Compatible with all Standard & Custom Columns
Mass spectrometry analysis
- Phosphorylation and Oxidation Analysis
- N/C Terminal Sequencing
- Sulfide Band analysis
- Peptide Mapping
- N/O Glycan Analysis
- Intact Mass
- PTM Analysis
Batch release Testing
- Sterility
- HCP Service (CHO, E.Coli and Yeast)
- HCD Service
- CHO, E.Coli, Yeast, BHK, SF9,
Sp2/0, CEF, MR5 and Vero - R&D service for new hosts
- CHO, E.Coli, Yeast, BHK, SF9,
- BET
- Quantitative Test (rFC)
- Qualitative Test (Gel Clot)
Physicochemical analysis
- PH, Physical Appearance, Osmolality, TOC & Conductivity
- Residual Analysis with HPLC and Mass
- Identity by HPLC, ICP
Impurities and contaminants
- Host Cell Protein (HCP) Analysis
- Host Cell DNA (HCD) Quantification
- Residual Protein A Analysis; Process-Related Impurity Testing such as Hentamycin, DMSO and Phenol Red
- Endotoxin Testing (LAL)
- Sterility Testing
- Bioburden Testing
- Mycoplasma Detection
- Residual Solvent Analysis
- Elemental Impurity Testing (ICP-MS)
- Leachables & Extractables Assessment
- Adventitious Agent Testing