Cell Bank Biosafety Testing and Characterization

Fully characterized, documented, homogeneous master and working cell banks are essential to reduce risk and ensure product safety and quality. Creative Biogene provides complete characterization of cell bank biosafety using GMP-validated assays as required by ICH Q5A regulations. Our cell bank development capabilities are combined with our extensive characterization services to provide our clients with solutions for all cell line safety testing and characterization needs.

Cell Bank Biosafety Testing and Characterization-1

Why Biosafety Testing and Characterization of Cell Line is Important?

The biosafety and characterization of cell banks is critical in the production of GMP cell lines, which is crucial for the subsequent control of biologics and is required by ICH regulatory guidelines. The purpose of these tests is to confirm the identity, purity and suitability of the cell substrate for manufacturing use. Specific testing strategies for characterizing cell banks vary depending on a variety of factors, including but not limited to the origin of the cell line itself, its growth requirements, and culture history.

Scope of Cell Line Biosafety Testing and Characterization

Creative Biogene has accumulated extensive experience in characterizing cell banks for biopharmaceutical products. We perform cell line characterization of all master cell banks (MCB), working cell banks (WCB), and end of production cell banks (EoPCB) involved in the production of GMP cell lines in accordance with global regulations, ensuring the identity, purity, and safety of the cells and resulting biologics.

Cell Bank Biosafety Testing and Characterization Strategy at Creative Biogene

The following table describes Creative Biogene's biosafety testing and characterization strategy using CHO cell lines as an example. These tests are mainly related to microbial contamination, cell line identification, genetic stability, and virus detection. Our specialized and flexible testing services include, but are not limited to, CHO cell lines, with customized tests available depending on the type of cell line (mammalian cell line, microbial cell line) and intended production use.

CHO Cell line Biosafety Testing and Characterization Strategy		MCB	WCB	EoPCB
Microbial contamination	Sterility	×	×	×
Microbial contamination	Mycoplasma	×	×	×
Cell line identity	DNA Barcoding	×	×	×
Genetic stability	cDNA/mRNA sequencing	×		×
	Southern blotting	×		×
	Northern blotting	×		×
	Genetic stability analysis by FISH	×		×
Virus testing	Endogenous and non-endogenous retroviruses: reverse transcriptase and retroviral infectivity assays	×		×
	In vitro assays	×		×
	In vivo assays	×		×
	Test for specific viruses such as: Bovine viruses, Porcine viruses, Minute virus of mice	×
	Antibody tests	×
	Transmission electron microscopy	√		√

Why Choose Us

We have the ability to characterize a variety of mammalian, insect, and avian cell banks, including master cell banks, working cell banks, and end of production cell banks.
We offer comprehensive safety testing services in the areas of microbiology, mycoplasma, genetic stability, viral safety and biochemistry to support our cell banking capabilities.
All of these services adhere to strict cGMP requirements and are designed to fully support the testing of biopharmaceutical products, including raw materials, cell lines, unprocessed bulk, purified bulk and final products.

As a leader in GMP cell line development services, Creative Biogene offers a wide range of biosafety and characterization tests required to release cell banks. All of our testing services are compliant with global pharmacopeial standards and are performed at FDA as well as EMA and MHRA accredited facilities. Please feel free to contact us if you have a need, and our experienced specialists will be happy to assist you.

* For research use only. Not intended for any clinical use.

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