Mammalian Expression Platform

Transcription

1 Mammalian Expression Platform Partners for Life Advancing tomorrow s medicines

2 w Your CDMO partner for biologics and advanced therapies Good science, experience and a quality driven approach Line/Strain Development As your partner, we help expedite this process by bringing our years of experience and our expression platform technologies for microbial expression, paveway ; and platforms and solutions for mammalian expression, Saturn and Apollo. Process Development At FUJIFILM Diosynth Biotechnologies our Process Development philosophy is driven by designing processes for a wide range of expression systems that result in having phase appropriate product controls that will result in successful process execution during cgmp manufacturing. cgmp Contract Manufacturing We offer our partners highly flexible clinical and commercial cgmp facilities for the production, by microbial fermentation and cell culture, of biologics and advanced therapies. Quality This is at the heart of everything we do. Quality drives the development and the successful production of your biologics and advanced therapy products from beginning to end, with propriety statistical design tools like RAPTA for Laboratory Process Characterization (LPC). CHO DG DHFR Vector Line Development Process Media & Feed Optimization Efficient and high quality cell line and process development is the critical first step in the development of a robust manufacturing process for expression of a therapeutic protein. FUJIFILM Diosynth Biotechnologies scientists have researched the key components in the generation of a recombinant cell line, and as a result have created our Apollo mammalian expression platform. Utilizing this platform will produce a high quality recombinant cell line to take your biopharmaceutical from pre-clinical through to commercial production. The benefits of our Apollo mammalian expression platform are: line for life Same cell line for pre-clinical, clinical and commercial production. Rapid clinical material Product titer up to 3g/L typically seen before media and feed optimization. Early representative material Transfectant pool and pre-clonal material available for pre-clinical use. Optimized cell line development process Animal component-free media and state-of-the-art screening technologies. Low regulatory risk High probability of monoclonality; CHO DG-derived cell line; fully traceable cell lines. Simple technology access Attractive licensing terms. Standalone or the starting point for Saturn mab Plus Apollo Line Development is an integral part of our Saturn mab programs but can also be a stand-alone solution. A cell line for life

3 Apollo delivers: transfection to RCB in weeks Selected rcho cell line(s) Transfection CLD TIMELINE (weeks) 1 1 Representative material available from transfectant pools 1 3 RCB of clonal cell line(s) available S tate-of-the-art multi-well plate (Figure 1) and micro bioreactor systems (Figure ) are utilized to screen cell lines in an environment that is closer to that of a production bioreactor Operated in fed-batch mode with cells in suspension culture Enables improved and early prediction of the best cell lines to progress igh probability of success H Large number of high titer cell lines. Shaken, Fed-Batch Multi-Well Plate mab A Shaken, Fed-Batch Multi-Well Plate mab A ambr1tm mab B Harvest Titer (g/l) Gene Sequence Performance: cell lines in shaken, fedbatch multi-well plate and ambr1 screens Product Concentration (g/l) Parental (pre-clonal) cell line(s) available for material supply point size: Qp Line 1 3 IVC (x 1 cells.h/ml) Figure 1: Example data from performance of cell lines T iters up to.3 g/l observed Figure : Example data from performance of top 1 cell lines Titers up to 3 g/l observed

4 Pooled transfections: fast and efficient supply of pre-clinical material S uccessful progression of four representative, high-producing cell lines to lab-scale bioreactors Utilizing same un-optimized day, fed-batch process as ambr1 Up to 1g 3 M aterial supply easily scalable from shake-flasks to 1L rocking bioreactor to L Xcellerex XDR Growth and productivity characteristics maintained E xample time frame: Gene synthesis to 1L supernatant in 1 weeks Gene synthesis to purified material from 1L supernatant in 1 weeks Line A A cell line for life Line B Line C Line D 3... Viable Density (x1 cells/ml) Culture Time (Days) Harvest Titer (g/l) P roduced in same cell line as used for clonal cell line development Example of Growth Profiles from a Transfectant Pool Assessed in Fed-Batch Shake Flasks Days 1. 1L Pool 1. 1L Pool 1L Pool Example of Productivity Profiles from a Transfectant Pool Assessed in Fed-Batch Shake Flasks. Line A Line B Line C Line D Titer (g/l) Viable Density (x1 cells/ml) Performance: cell lines in lab-scale bioreactors Days 1L Pool 1L Pool 1L Pool 1

5 Belasis Avenue, Billingham TS3 1LH, United Kingdom Tel: + () J. Morris Commons Lane, Morrisville, North Carolina 7, USA Tel: +1 (919) Discovery Drive, Suite, College Station, Texas 77, USA Tel: +1 (979) contactfdb@fujifilm.com Apollo is a trademark and the property of FUJIFILM Diosynth Biotechnologies UK Limited. paveway is a trademark and the property of FUJIFILM Diosynth Biotechnologies UK Limited. Saturn is a trademark and the property of FUJIFILM Diosynth Biotechnologies UK Limited. FUJIFILM Diosynth Biotechnologies UK Limited. June 17