https://www.brcbiotech.com/platforms-technologies/cell-biology.html
Cell Biology Platform
Facility Environment
Platform Advantages
Testing Capabilities
BRC Cell Biology Platform focuses on providing customers with comprehensive services, including the construction of cell sample banks, cell identification and amplification preparation, and cell therapy drug testing. The cell lines used in this platform are sourced from internationally renowned cell preservation institutions and come with cl... morehttps://www.brcbiotech.com/platforms-technologies/cell-biology.html
Cell Biology Platform
Facility Environment
Platform Advantages
Testing Capabilities
BRC Cell Biology Platform focuses on providing customers with comprehensive services, including the construction of cell sample banks, cell identification and amplification preparation, and cell therapy drug testing. The cell lines used in this platform are sourced from internationally renowned cell preservation institutions and come with clear and complete documentation of origin. Additionally, BRC Biotechnology has completed strict cell bank construction and GMP release testing processes for these reference samples, strictly following relevant regulatory requirements to implement full-process quality control for the reference cell lines, ensuring they meet high-quality standards.
#gmp #cell #banking
https://www.brcbiotech.com/services-solutions/rapid-testing.html
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 technol... morehttps://www.brcbiotech.com/services-solutions/rapid-testing.html
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.
CelerQ® 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 Biotech provides comprehensive cell line characterization, raw materials, bulk harvest and drug product testing. We cover antibody products, gene cell therapy, vaccines and other applications.
#Celer #Q
