The timeline maintains a robust cloning strategy with one round of cloning.
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 reduction of cell line development timelines with its Apollo X™ Advanced Mammalian Expression System.
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 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.