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Centre of Excellence in Biopharmaceuticals ( CoEBP ) Alan Dickson The University of Manchester

NEPIC Innovation Day, November 15 th 2011. Centre of Excellence in Biopharmaceuticals ( CoEBP ) Alan Dickson The University of Manchester. Background: Science Need CoEBP CoEBP : What can we do Success to date Future plans Contacting us. Source Evaluate Pharma 2010.

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Centre of Excellence in Biopharmaceuticals ( CoEBP ) Alan Dickson The University of Manchester

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  1. NEPIC Innovation Day, November 15th 2011 Centre of Excellence in Biopharmaceuticals (CoEBP) Alan Dickson The University of Manchester • Background: Science Need • CoEBP • CoEBP: What can we do • Success to date • Future plans • Contacting us

  2. Source Evaluate Pharma 2010

  3. Science Need Predicted Top Ten Therapeutics for 2016 Source Evaluate Pharma 2010

  4. Science Need Transcription RNA processing Translation Secretion Amount Quality Purity Properties Bioprocessing

  5. Science Need Bioprocess – biopharmaceuticals, biologics • Bioprocess - activities that enable design, development • and production of biological medicines both • in bulk and final dosage form • Includes • Cell line development and cell banking, • Fermentation processes, • Recovery and purification processes, • Chemical modification, • Formulation process and dosage form, • Storage and stability, • Analytical methods, • Final product and stability testing

  6. Science Need Biopharmaceuticals: Current commercial reality 58 new biopharms products approved 2006-2010 32 – Chinese hamster ovary (CHO) cell 17 – E.coli 4 - S. cerevisiae 2 - Transgenic animals 2 - Insect cells 1 - Pichiapastoris(GlycoFi) Walsh, G [2010] Nature Biotechnology 28: 917-924

  7. Science Need Immunoglobulin structure Commercially valuable Complex – IgG 150,000Da Aspirin 180Da Possible modifications 100 Billion combinations Functional quality R. Jefferis (2006) Nature Biotech. 24: 1230-1231 Structure generated by Peter Artymiuk (University of Sheffield, Sheffield, UK) using PyMOL (http://pymol.sourceforge.net/).

  8. Science Need • The challenge of • “improved” products • The complexity of • the biological system Antibody (mAb) Fab scFv scAb

  9. Science Need The Biopharmaceuticals “pipeline”/system Required product (vs target) Expression system Helping with industrial challenges Scale-up and quantity Downstream processing/purification Formulation/storage Patient delivery

  10. The CoEBP Centre of Excellence in Biopharmaceuticals (COEBP) A short history • BIGT Report 2003 – maintaining UK position/investment • bioProcess UK (KTN) 2005 – industry/BRIC funding (£13M) • bioProcess UK 2006 – call for new Centres (especially training) • BRIC funding 2006/7– 19 companies/24 academic projects • Potential new Centres “anointed” 2007 – support (non-financial) • COEBP and NWDA 2007 onwards – application(s) from UoM • COEBP and ERDF/NWDA 2009 – application funded Oct 2009 • BRIC2 2010 – evolving industry funding route (£10M) • COEBP 2010 - staff appointments May 2009 • COEBP 2010 – robotics facility complete December 2010

  11. The CoEBP Discovery Development Commercial Target identification Lead identification Lead optimisation Marketing/sales Manufacturing Supply chain Pharmaco-vigilance Manufacturing Pharmaceutics Formulation/delivery Pre-clinical Clinical Toxicology Discovery Bioprocessing* Formulation* Delivery* Toxicology* Clinical Research Diagnostics

  12. The CoEBP Centre of Excellence in Biopharmaceuticals (COEBP) Key activities: • Direct Business Support • Academic/industrial research collaborations • Exchange placements – industry/academia • Work-based Training • Establishment of Robotics capability • “New academic involvement” • engagement of “naïve” academics • with the biopharms sector • application of new technologies • and approaches to the sector TAP Thermo

  13. What can we do? Pharmacy/ formulation, delivery Systems biology Chemical engineering Structural biology Cell and molecular biology CoEBP Computational biology Physical sciences/ mathematics Toxicology/ immunogenicity Analytical scientists

  14. What can we do? Knowledge transfer/ training activities Industry advisory consultancies Advisory services to the sector Contract services CoEBP Research Funding (underpinning) Direct industry funded research (project/PhD) Collaborative industry research (project/PhD)

  15. What can we do? Sonata – Protein Expression Automation Mammalian Suspension Cell Culture Biologics Process Development − Culture Optimisation − Stability Studies − Scale-up Research & Drug Discovery − Protein Reagent Supply Accelerating development of Biopharmaceuticals

  16. What can we do? • Thermo Fisher Momentum F5 • Complete processing microtitre plates • High throughput capability • High content capability • Automated cell/reagent dispensing • Assay and screening automation • CellomicsArrayscan • Imaging of individual cells • Automated data handling and storage Accelerating development of Biopharmaceuticals

  17. Success to date 17 Internal research programmes undertaken – 12 completed and some form grant applications, 5 on-going) 5 Research Council Project grants (£2.1M) 7 externally-funded PhD studentships Grant applications >£12M under consideration 6 Industrial group PhDs under discussion External Engagement 30 UK-based companies (14SMEs, 16 LOs) 5 EU/USA-based (1 SME, 4 Los) 3 directly-funded research contracts 5 programmes under discussion (2 technology evaluations) (3 research collaborations) Seminars and training modules (Aggregation, Systems Biology, Analytics) Advisory roles in consultancies and advisory committees 21 “Core” Academics 40+ 2° Academics

  18. Success to date Best? Growth rate, IVC,Qp, PTM and secretion, selective product handling, feed response Find the best cell (clone)?

  19. Success to date CHO clone selection – GFP cherry picking ThermoFisher System

  20. Success to date CHO Cell line (in)stability Specific productivity Cell growth Generation time Sonata TAP System

  21. Success to date Primary Neurone Screening ThermoFisher System

  22. Future plans Knowledge-based BioEconomy Research Vision Industrial Biotechnology - Bioprocessing - Funding bodies priorities - Strategic challenge UoM Long-term academic research funding – recruitment Short-/medium term industrial exchange/training Increased SME networking Increased generic training

  23. Contacting us http://www.coebp.ls.manchester.ac.uk

  24. University of Manchester Centre of Excellence in Biopharmaceuticals Professor David Clarke Dr Simon Merrywest Dr Joanne Flannelly Dr Annes Lambert Professor Ian Kimber Professor Pedro Mendes Dr Aline Miller Ms Rachel Ashworth Dr Malcolm Rhodes Professor Mike Sutcliffe Dr EgorZindy COEBP Scientific Advisory Board The Dickson lab group and funders BBSRC BRIC (BBSRC/EPSRC/Industry) GlaxoSmithKline Life Technologies Lonza Biologics MedImmune (CAT) Pall Pfizer RecipharmCobraBiologics UCB Celltech Dr Kevin Cox Dr Geoff Davison Prof Douglas Kell Dr Mark Douglas Dr Ian Madley Dr Linda Magee Dr Daniel Smith

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