The introduction of new single step cloning technology, in combination with the new Apollo X host cell line has allowed development timelines to be significantly reduced. The Apollo X Advanced Mammalian Expression System allows for cell line development for monoclonal antibody expression in 10 weeks (transfection to generation of research cell banks) using Cambridge-based Sphere Fluidics Cyto-Mine® Technology followed by Cell Metric® (Solentim) plate-based imaging.
This approach allows Fujifilm to provide visual evidence of monoclonality from different instruments and at different time points. The workflow provides a high probability of monoclonality (>99%) and the cloning method is also supported by experimental and statistical data for multiple cell lines and model monoclonal antibodies.
"The accelerated timeline moves the bottleneck in cell line development from one that is limited by the need for multiple screening and cloning steps to one that is limited by cell doubling time," said Fay Saunders, head of upstream mammalian cell culture, process development, at FUJIFILM Diosynth Biotechnologies, U.K. site.
The Apollo X Advanced Mammalian Expression System is capable of delivering industry leading titres in excess of 10g/L and is a "manufacturing ready" cell line with a robust support package to aid IND filing.
About Fujifilm
FUJIFILM Diosynth Biotechnologies an industry-leading Biologics Contract Development and Manufacturing Organization (CDMO) with locations in Billingham and Redcar, UK, RTP, North Carolina and College Station, Texas. FUJIFILM Diosynth has over twenty five years of experience in the development and manufacturing of recombinant proteins, vaccines, monoclonal antibodies, among other large molecules, viral products and medical countermeasures expressed in a wide array of microbial, mammalian, and host/virus systems. The company offers a comprehensive list of services from cell line development using its proprietary pAVEway™ microbial and Apollo™ cell line systems to process development, analytical development, clinical and FDA-approved commercial manufacturing. FUJIFILM Diosynth Biotechnologies is a partnership between FUJIFILM Corporation and Mitsubishi Corporation. For more information, go to: www.fujifilmdiosynth.com.
FUJIFILM Holdings Corporation, Tokyo, Japan brings cutting-edge solutions to a broad range of global industries by leveraging its depth of knowledge and fundamental technologies developed in its relentless pursuit of innovation. Its proprietary core technologies contribute to the various fields including healthcare, graphic systems, highly functional materials, optical devices, digital imaging and document products. These products and services are based on its extensive portfolio of chemical, mechanical, optical, electronic and imaging technologies. For the year ended March 31, 2018, the company had global revenues of $23.0 billion, at an exchange rate of 106 yen to the dollar. Fujifilm is committed to environmental stewardship and good corporate citizenship. For more information, please visit: www.fujifilmholdings.com.
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SOURCE FUJIFILM Diosynth Biotechnologies