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
Ensuring viral safety is a critical requirement in the development and manufacturing of biopharmaceutical products. At LivGen Pharmed, we provide Viral Clearance Studies to evaluate and validate the effectiveness of manufacturing processes in removing or inactivating potential viral contaminants. Our studies are designed in accordance with GLP guidelines, supporting regulatory submissions and ensuring the highest standards of product safety.
Mass spectrometry analysis
MS is one of the most powerful analytical technologies used in biopharmaceutical quality control. It enables highly accurate identification, molecular weight determination, and structural characterization of proteins, making it an essential tool for biosimilar comparability assessment and quality evaluation.
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