Ellie Hawke Industrial Placement Student FUJIFILM - PowerPoint Presentation

1. Ellie HawkeIndustrial Placement Student FUJIFILM Diosynth BiotechnologiesConfidential1

2. Presentation overview BackgroundMy placement experienceAn introduction to FUJIFILM Diosynth My experiences at FUJIFILM DiosynthAdvantages of an industrial placement2

3. BackgroundInitially applied to BSc in Biochemistry.Transferred onto Biomedical Sciences at the end of my first year.Currently undertaking an Industrial Placement Year at Fujifilm Diosynth.As a result of my placement year I now have aspirations to complete a PhD and return to industry.Confidential3

4. My placement experience4Up until the early part of second year I had no aspirations to undertake an industrial placement year.Attended placement talks and started to prepare CV.Application process InterviewStart

5. An introduction to Fujifilm Diosynth.cGMP Contract Development and Manufacturing Organisation (CDMO)Based in Billingham, Wilton, North Carolina and Texas.Various departments including : - Protein expression- E.coli, Yeast and CHO capabilities. - Downstream purification - Analytical services - Large scale manufacturing Confidential5

6. My experiences at Fujifilm Diosynth – an introduction to BiologicsUtilisation of the internal cell machinery to manufacture drugs.More complex drugs require different expression systems.No post translational modifications required; E. coli could be used. If post translational modifications are required, such as glycosylation, a mammalian expression system would be used.In Mammalian Cell Culture we are producing monoclonal antibodies using a CHO expression system. Apollo™’ – a standard platform process we follow, producing a stable cell line expressing the desired antibody. Confidential6

7. Apollo™ CLD processConfidential71) Transfection & selection4) Animal component free limiting dilution cloning6) ambr15™ Screen7) Research cell bank5) Expansion, second 96-well plate screen & second shaken, fed-batch multi-well plate screenClone-27Vector8a) Cell line stability study2) First screening & cloning step: ClonePix™23) Expansion, first 96-well plate screen & first shaken, fed-batch multi-well plate screen8b) Cell banking activities

8. Experience – The Cytomine.Sphere Fluidics Cyto-Mine® Technology.Based on a FRET-assay which allows the sorting of picodroplets.The cytomine is a high-throughput instrument that uses picodroplet technology and microfluidics to process up to 40 million heterogeneous mammalian cells in less than a day.Confidential8

9. ExperienceConfidential9Currently the 18 week timeline includes 2 cloning steps but with the implementation of the cytomine CLD timelines can be reduced to 10 weeks.Whilst working at Fujifilm I have been working to try and validate the cytomine machine as a monoclonality assurance method so that it can be used in CLD processThis ultimately speeds up the delivery of customer projects without compromising product quality.

10. CytoMine WorflowConfidential101)Sample LoadingThe prepared cell suspension and assay reagents are loaded into a Cytocartridge and the Cytocartridge is loaded into the machine. 2) Picodroplet generationCells and assay reagents are encapsulated into picodroplets. Hundreds of thousands of cells can be encapsulated and processed in a single run.3) Productivity screenPicodroplets are incubated. Cells secrete antibody product and due to encapsulation, the product produced by a single cell can be detected.4)Droplet sortingPicodroplets which have the highest productivity are selected.5) Single droplet dispensingSelected picodroplets are dispensed into a well of a 96 well plate. 5 images are taken pre dispensing and a heat map of the 96 well plates is produced.6) 96 well plates are imaged at set time points using the CellMetric™. Colony formation can be tracked back to the single cell stage.

11. Advantages of an Industrial Placement Boosts employability- experience in specific field that will make you stand out from other candidates when it comes to applying for jobs, masters/PhD’s following graduation.Work with latest new technologies- experience with new technologies and high throughput methods such as the cytomine, AMBR 15 and Tecan.Transferrable skills- independent working, working as part of a team, time management…Networking-making contacts with professionals in industry will be useful when searching for a future job and receive unlimited career advice from someone with a lot of experience.Hands on experience in a real science environment- insight into what working in industry is actually like that you would not get from degree alone.Confidential11

12. Questions?Confidential12