Titres achieved are in excess of 10g/L without compromising product quality
BILLINGHAM, England/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 2024through 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.