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In recent years, the development of global biopharmaceutical industry is in a period of rapid rise. Among them, cell and gene therapy drugs and antibody drugs have written a new chapter of innovative biopharmaceuticals. However, the development of stable and efficient cell lines is indispensable for the production of antibodies, fusion proteins, vaccines and other biotherapeutic drugs. Creative Biogene has a leading cell line development laboratory and GMP cell line production facility. We specialize in providing innovative solutions for the entire process of GMP cell line production, including cell culture process development, optimization, characterization scale-up and quality control for clinical and commercial production of biopharmaceuticals.
Cell line development is a complex process. The steps to create stable, high-yielding cell lines for production include: host cell line selection, expression vector engineering, transfection, cloning and cell expansion, and various screening steps to select monoclonal cell lines with high cell viability, high growth capacity, and the highest performance in terms of expression level, as well as stability and quality of expression profile. In this process, Creative Biogene employs a variety of different strategies to optimize the cell line development workflow, providing robust and high-quality cell lines to support the project development demands of its diverse customers.
The combination of host cell lines, vector design and rigorous screening allows us to provide our customers with highly productive cell lines suitable for commercially relevant processes. Creative Biogene has created a standard cell line development process and provides continuous optimization of technology for robust, efficient, and scalable cell line development throughout the production process.
Creative Biogene has extensive experience and expertise in vector design and construction. We can provide comprehensive gene synthesis, plasmid construction and virus packaging services and sequencing of target sequences for subsequent transfection to ensure efficient cell line production to meet diverse development demands.
Screening and characterization of cell lines is involved in several steps of the GMP cell line development and production process, including initial clone screening, post-transfection screening, and monoclonal screening. It is critical to screen a large number of clones as quickly as possible to select valuable clones for further analysis. Creative Biogene uses high-throughput analysis and screening techniques to precisely and efficiently discover and characterize target cells to facilitate the generation of fully characterized, documented, homogeneous cell banks for subsequent GMP cell line production. In addition, we perform rigorous and meticulous testing on the selected cells to ensure their genetic stability and to ensure that they are free of any pathogens and other unknown factors.
In the large-scale production of cell lines, clone screening and cell culture, which are the core of the upstream process, require a lot of effort. Creative Biogene offers process development for different culture modes during cell line project development and production, including traditional batch replenishment, continuous or enhanced upstream processes, process characterization and process validation for all phases of cell line production. We are committed to using high-throughput, standardized, automated cell culture and process optimization to help us accelerate cell line development while obtaining more accurate results.
Creative Biogene can provide cell line production services with high scale-up stability from small-scale studies to cGMP production levels. After the cell line development process is complete, we can use the resulting high quality cell bank for transfer to a CDMO of the customer's choice for further process development, optimization and high level GMP production.
Creative Biogene provides custom cell line development solutions for our clients' unique processes. Our robust manufacturing capabilities and access to cGMP compliant technology platforms can accelerate your cell line development and smoothly transition to scale up to commercial production. Please feel free to contact us if you have a need, and our experienced specialists will be happy to assist you.
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