Our Rapid Testing solutions are designed to streamline biopharmaceutical development and manufacturing by providing fast, accurate, and regulatory-compliant results. Combining advanced NGS-based adventitious testing with ready-to-use residual detection kits, we empower researchers and manufacturers to accelerate product release, ensure biosafety, and maintain the highest standards of quality.
NGenius®: Our platform of NGS technology to deliver compliant, efficient, sensitive adventitious virus detection, accelerated biosafety release of biologics.
Celer Q® Detection Kit: Ready-to-use residuals detection kit for safe and reliable biopharmaceuticals production.
Cell Substrate Characterization
Cell substrate is an important raw material in biologics production. It is categorized as primary cell, diploid cell, stem cell and continuous cell lines in accordance with the origins and characteristics. To ensure the quality of biological products, it requires the full understanding of the cell characteristic and reduction of exogenous agent presence in the cell lines. Comprehensive cell line characterization will bring high quality and safety to biological products.
Strategy for Cell Substrate Characterization
The cell substrate characterization should be fully considering the cell properties, product characterization and the regulatory requirements. Cell line used for biopharmaceuticals should be tested for cell identity, free of culturable bacteria, fungi, mycoplasma and infectious viruses, including potential pathogens. Animal pathogens, which is not normally found in the cell substrate, should be considered as well as endogenous retroviruses.
BRC solution for cell substrate characterization
BRC biotechnology provides comprehensive cell line characterization, raw materials, bulk harvest and drug product testing.
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