Published on September 24, 2014
FUJIFILM Diosynth Biotechnologies Introduces: For more information, visit: www.FujifilmDiosynth.com/Apollo
Who is Fujifilm Diosynth Biotechnologies? Fujifilm Diosynth Biotechnologies is a leading global Biologics Contract Development and Manufacturing Organization We have locations in Billingham, UK and Research Triangle Park, NC, USA. We have industry leading experience with Over 230 Development and Manufacturing Projects. We are licensed to manufacture five (5) commercial products.
Regulatory Approval Launch Phase III Phase I Phase II Preclinical Gene Expression & Strain / Cell Line Development Process Invention Pre-clinical Manufacture Process Development & Optimization Analytical Development Formulation Development (DS, DP) cGMP Manufacture Process Characterization Process Validation cGMP Manufacture cGMP Stability (DP, DS) Commercial Production Post-approval Activities A long-term Partner through Product Lifecycle View slide
Full Service Cell Culture Offering • Proprietary host cell line • Proprietary vector • Media/Feed Platform • CLD Process Process and Analytical platform cGMP Manufacturing platform • mAb DSP Platform • Platform mAb analytics • cGMP cell banking • 160-2000L SS cGMP plant (US) • 200-2000L SU cGMP plant (US & UK) View slide
What is the Apollo™ platform? • Apollo™ is a mammalian expression platform developed by FUJIFILM Diosynth Biotechnologies’ scientists. •Apollo™ was created with manufacturability as an end- goal. •Apollo™ will deliver a high quality recombinant cell line to take your biopharmaceutical from pre-clinical through to commercial production. Apollo™, a cell line for life.
Components of the Apollo™ mammalian expression system
Summary of FDB Mammalian Cell Line Development and Upstream Process Development R & D Services Vector design and construction Transfection Expansion and selection Cloning Expansion and selection RCB Cell line stability study Process establishment Process demonstration Process development / optimization cGMP MCB / WCB cGMP manufacturing Process characterization Cell Line Development Process Development
Apollo™ Components: Host Cell Line Adapted to CD media Host cell line CHO DG44 derived Fully characterized cGMP cell bank of host cell line with maximum traceability Developed using a directed evolution approach Selected for superior growth characteristics and expression capability Adapted to chemically defined medium and suspension culture
Apollo™ Components: Vector Adapted to CD media DHFR based selection system High productivities achieved without the need for amplification Vector Double gene vector for mAbs Proprietary leader sequence developed for efficient secretion Codon optimization utilised
Adapted to CD media Animal component-free media and reagents throughout cell line development Up to 3 g/L typically seen pre-optimization Pooled transfection and / or clonal cell line development State-of-the-art screening strategies Process Robust cloning strategy: high probability of monoclonality Apollo™ Components: Process
• From preclinical to market • Regulatory friendly • Rapid Clinical material • Early representative material •Attractive terms What are the Benefits? Speed Business friendly
2) First screening & cloning step: ClonePix™ 2 1) Transfection & selection 3) Expansion, first 96-well plate screen & first shaken, fed-batch multi- well plate screen 4) Second cloning step: ACF limiting dilution cloning Our Cell Line Development Approach 6) ambr15™ Screen 7) Research cell bank 5) Expansion, second 96- well plate screen & second shaken, fed-batch multi-well plate screen Transfection to RCB of clonal cell line = ~25 weeks Possible program break point Generation of material from transfectant pools Stability study, Process Development, etc.
Apollo™ Timeline Time (weeks) 1 . . . 5 . . . .10 . . . . 15 . . . . 20 . . . . 25 Vector construction Cell line Representative material (transfectant pools) Pre-clonal cell line for DSP & early supply RCB of clonal cell line
Summary: The Apollo™ System Key aspects of the expression system are: • DHFR based selection system − High productivities achieved without the need for amplification • DG44 derived host cell line − Adapted to chemically-defined medium and suspension culture − Selected for superior growth characteristics and expression capability − Fully characterized cGMP cell bank of host cell line with maximum traceability • Optimised cell line development process − Animal component-free media and reagents for the complete cell line development process − High probability of monoclonality (experimental and statistical evidence to support approach) − Inclusion of state-of-the-art screening technologies, allowing improved prediction of the ‘best’ cell lines to progress: ClonePix™; fed-batch, shaken multi-well plate system; Ambr15™ • Product concentrations up to 3 g/L typically seen pre-optimisation − FUJIFILM process development strategy available for further optimization
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