Our promise to you:
Guaranteed product quality, expert customer support.
24x7 CUSTOMER SERVICE
CONTACT US TO ORDER
The genetic stability of a cell line is a key analytical property needed to demonstrate changes in cell quality over time. Crerative Biogene offers a variety of advanced techniques for assessing the stability of cell lines. We guide you through each GMP cell line production system and project phase to accelerate your project development process.
Genetic stability testing is a key component of production cell bank characterization, which is also a regulatory requirement. Typical mammalian production cell lines are created by stable transfection of expression vectors into host cell lines. During subsequent cell culture, genomic events such as deletions, rearrangements and point mutations may occur and result in changes in cell phenotype or gene expression profile. Instability of cell lines is of great concern as it may negatively impact the integrity of the product, thus posing a risk to patients. Even when product integrity is not compromised, the risk of reduced cell productivity and possible future instability events remains a high concern from an operational standpoint.
Creative Biogene offers a variety of advanced technologies for testing the genetic stability of cell lines. These tests are performed throughout the life cycle of the production cell line and assess the genetic stability of the master cell bank (MCB), working cell bank (WCB), and end-of-production cells (EOPC).
Typical genetic stability testing services we offer include the following:
DNA barcoding is the most cost-effective and efficient method for confirming the identity of cell lines. Creative Biogene offers DNA barcoding for the characterization of GMP cell lines. We use the barcode to confirm the identity of cell lines at the species level by using information from several genetic regions.
Creative Biogene uses cDNA/mRNA sequencing to confirm cell line stability based on the nucleic acid sequences of the transgenes used to produce target proteins and flanking regions.
Southern blotting identifies the presence of transgenes in DNA digests of production cells, demonstrating their integrity. We analyze the genomic structure of the integration site by Southern analysis of the restriction zymogram to reveal approximate information about the transgene copy number.
Creative Biogene combines northern blotting with cDNA/mRNA sequencing, resulting in a determination of the integrity of the product transcripts.
qPCR is widely used to detect changes in gene copy number, mRNA expression and plasmid DNA levels. qPCR is used by Creative Biogene to determine the transgene copy number of each cell and combined with DNA sequencing and restriction map analysis for genetic stability testing of cell lines.
Creative Biogene has extensive experience and strengths in using FISH to study the genetic stability of cell lines. With FISH, we can visualize the transgene integration pattern and compare the results of MCB and EOPC analyses to provide insights into the stability of cell lines.
Creative Biogene combines our advanced technology and extensive expertise to provide rapid and comprehensive genetic stability testing of cell lines to accelerate your project development. Please feel free to contact us if you have a need, and our experienced specialists will be happy to assist you.
Copyright © Creative Biogene. All rights reserved.