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
Through comprehensive Batch Release Testing services, LivoGen Pharmed ensures that every biosimilar batch meets stringent quality standards and supports the delivery of safe, effective, and reliable biopharmaceutical products.
Physicochemical analysis
Physicochemical Analysis is a fundamental component of biopharmaceutical quality assessment, providing detailed insights into the structural and functional characteristics of biological products
R&D and Scientific Consulting Services
Successful quality control of biopharmaceutical products requires scientific expertise, robust analytical methodologies, and a thorough understanding of international regulatory requirements. At LivoGen Pharmed, we provide specialized R&D and scientific consulting services focused on quality control, analytical characterization, and laboratory excellence. From analytical method development and validation to troubleshooting, biosimilar quality assessment, and regulatory support, our experts deliver tailored scientific solutions that strengthen quality systems, optimize analytical performance, and ensure compliance throughout the product lifecycle.