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The viral vector manufacturing process involves a multi-step approach and technique that requires specific production cell lines, production facilities, and specialized operators. Creative Biogene is a one-stop provider of viral vector CDMO services, providing solutions for the whole process from cell bank and virus seed bank establishment, upstream and downstream process development, to quality control analysis. Our professional development team is committed to helping clients obtain scalable and cost-effective processes suitable for GMP production environments to meet their clinical development demands.
Creative Biogene offers a variety of flexible methods and expertise to help clients provide customized solutions to meet their demands at every step of the following viral vector production.
Cell Bank and Viral Bank Establishment
The manufacturing process of viral vectors is mainly based on the use of mammalian cells, such as the HEK293 cell line, in adherent or suspension cell systems. Creative Biogene has stable and high-yield viral vector production cell lines and has developed mature cell banks and viral bank build-ups, which can be defined according to the type of vector produced. Our experienced scientists can help you easily set up research cell banks, master cell banks, working cell banks, master virus seed banks, and working virus seed banks for subsequent viral vector production.
Upstream Process Development
The upstream process of viral vectors mainly includes steps such as adherent or suspension culture of HEK293 or mammalian cell lines, transfection of plasmids, harvesting and lysis of cells, and analysis. To address the various challenges faced in large-scale manufacturing, Creative Biogene has developed a variety of culture systems for viral vector production, primarily defined by the type of vector to be manufactured and the type of cell used. Our flexible and scalable upstream processes are moving to larger single-use culture systems and bioreactors that can accommodate large-scale manufacturing of any viral vector.
Downstream Process Development
The downstream processes of viral vectors mainly include filtration, capture, purification and other steps, involving the selection of various purification methods and processes. Creative Biogene offers a variety of reliable purification options, including ultracentrifugation, chromatographic purification, and TFF-based purification. Our advanced technology ensures that shear forces are minimized during the filtration step to maintain virus integrity and infectivity.
Quality Control Testing
Creative Biogene performs rigorous quality control analysis protocols during the production of viral vectors to ensure that all our production batches meet GMP regulatory requirements and standards. Our professional quality control team performs comprehensive analysis in functional testing, purity testing as well as safety testing of products to ensure that we provide customers with safe, effective and high-quality viral vectors.
Creative Biogene specializes in scalable manufacturing of GMP viral vectors, and we are committed to providing clients with personalized services throughout the entire process of viral vector production to drive flawless clinical and commercial GMP manufacturing. 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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