TITRES ACHIEVED ARE IN EXCESS OF 10g/L WITHOUT COMPROMISING PRODUCT QUALITY
BILLINGHAM, England, Jan. 10, 2019 /PRNewswire/ -- FUJIFILM Diosynth Biotechnologies (Fujifilm), a leading Contract Development and Manufacturing Organization (CDMO) with experience in the development and manufacture of recombinant biopharmaceuticals and gene therapies, has announced the introduction of its next generation Apollo mammalian expression system, Apollo X. The Apollo X advanced mammalian expression system is capable of delivering industry leading titres in excess of 10 g/L. This marks another milestone in Fujifilm's growing cell culture capabilities and highlights the success of Fujifilm's internal innovation programs.
Apollo X is designed to be a 'manufacturing-ready' cell line with a robust support package to aid IND filing.
"We have focused on optimizing the cell line development process without compromising quality," said Andy Topping, chief scientific officer at FUJIFILM Diosynth Biotechnologies. "And we have achieved that while reaching titres of 10g/L and higher in fed-batch processes."
Apollo X consists of four key components: (1) a CHO-DG44-derived host cell line selected through a directed evolution approach to control and manage cellular heterogeneity. The selected cell line has been fully sequenced and analyzed; (2) a novel expression vector with a proprietary leader sequence developed for efficient secretion and high productivities without the need for amplification; (3) a proprietary cell culture medium, developed in-house by the Fujifilm group, specifically screened for achieving high titres by monitoring initial cell growth, controlling peak cell density and maintaining high cell viability; (4) streamlined units of operations for efficient process implementation.
Apollo X cell line development timelines have been reduced by 30%, from gene to clonal cell line compared to the original Apollo expression system.
Fujifilm has been aggressively expanding its cell culture capacity at all of its sites since the initial launch of Apollo in 2014.
Under its bio CDMO business newly established in March 2017, FUJIFILM Corporation, the parent company of Fujifilm, seeks to achieve 100 billion yen in sales in the CDMO business by fiscal year ending March 2024 through aggressive capital investment and the development of highly efficient and highly productive technologies. The company also seeks to contribute to the further advancement of the pharmaceutical industry through the stable supply of high quality pharmaceutical products.
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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