BioUetikon Brand Audit


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Presentation of the biopharmeceutical company BioUetikon, comprising a general presentation on the company, marketing considerations, and specific issues regarding building the company.

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BioUetikon Brand Audit

  1. 1. BioUETIKON Limited Oct 200927/03/13 1
  2. 2. Agenda□ General Presentation of the company:□ Marketing consideration:  Target audience profile  type of clients (current and prospects)□ Specific issues that you may have:  Improve brand awareness EU & US  Reach a target audience as a new entrant  Gain credibility as a competent CMO for development and GMP production
  3. 3. Mission Statement□ BioUetikon provides high quality Process Development/Optimisation and cGMP Bioproduction Services. BioUetikon actively works to achieve a leading position in development and execution of efficient bio-processing systems to maximise value to clients, shareholders and employees.27/03/13 3
  4. 4. BioUETIKON Services Menu  BioProcess Development/Optimisation  Cell Line Development*  GMP Cell Banking & Storage  cGMP Production in multi-suite facility  Mammalian/Insect Cell Culture  DSP Development and Processing  Analytical Development  Quality Assurance/ In house QP  In House Microbiology/Environmental  Contract Based Research with NICB/NIBRT/CBAS/DCU  >10 years experience of project delivery * with partner Fusion Antibodies Limited27/03/13 4
  5. 5. Where does BioUETIKON fit in?Discovery Development MarketTargetsHitsLeads BioUETIKON Pre-clinical Development Phase 1 Phase 2 Phase 3 Submission /Approval Lifecycle ManagementCandidates1-5 yrs 0.5-2 yrs 1-2 yrs 1.5-3.5 yrs 2.5-4 yrs 0.5-2 yrs 10-20 yrs GMP Requirement 27/03/13 5
  6. 6. Experience□ Full compliance with international quality standards like cGMP, EMEA, FDA, ISO 13485□ Investigational Medicinal Products Authorisation (Ref. no.-057) Irish Medicines Board□ Obtained Manufacturing License 1995  renewed in 1998, 2001, 2004□ Passed All Inspections regulatory & quality audits (IMB, ISO, Client)□ Successful Track Record  Biologic API Production History (e.g. FSH for 10 years)  API Process Development (e.g. Biosimilar EPO)  Implant Device Development & GMP Production27/03/13 6
  7. 7. Business Concept ‘Simple’□ BioUETIKON is a pureplay CMO  Development thro’ GMP production  Fee for service model  Client part of project plan and may participate operationally where relevant  Client retains full IP  Transparency and Confidentiality at every stage27/03/13 7
  8. 8. Business Concept□ Partner Support with  QA GMP batch release Testing  Cell Line Testing and Characterisation  Virus Clearance Safety Testing  Formulation/Fill finish/Stability  Regulatory Support  Research & Development Services □ Cell Engineering & Development □ Media Screening □ Sequencing □ Sophisticated Analytics27/03/13 8
  9. 9. Project Management & Control□ Dedicated Project Manager□ Regular Review and Planning Meetings (Tele/Videocon, face to face meetings)□ Client Work on site as appropriate to progress to next project phase.□ Transparent Service□ Confidential Service New Customer Confidentiality Enquiry Agreement27/03/13 9
  10. 10. BioUETIKON Organogram27/03/13 BioUETIKON Limited 10
  11. 11. Parent company cph overview□ Swiss Industrial Group□ Founded 1818□ ~ 600M CHF Sales□ ~ 900 employees□ Profitable□ > 185 Yrs in Business□ Continuous Investment□ International27/03/13 11
  12. 12. Operating Division: CU Chemie Uetikon GmbH CPH Fine Chemistry Division Flat and efficient organisation - two reporting levels will minimise overheads and speed up communication Long term investment strategy and stable financial background Full service provider - from development through production to registration Broad and strong technology base - all key technologies available Excellent regulatory track record with authorities like FDA (USA), EMEA (EU), and PMDA (Japan) Profound R&D and production know how to serve our customers through all project phases (…from kilogram to ton…) 12
  13. 13. GMP Facilities BioUETIKON, Dublin□ High Quality Manufacturing Suites with fully independent ambient and 4oC Grade C production environment□ 3 Separate Cell Culture Suites for multi-product projects with multiple air-handling systems□ 3 Separate DSP Suites (2 are 2-8oC)□ Unidirectional people & material flow□ Separate Media Prep & Support Areas□ Cold storage (100m2 +4oC Rooms, various -20oC etc.)□ Secure Access, Alarmed, Monitored LN2 storage□ Room for Expansion  Development and GMP space available (e.g. long term client projects)27/03/13 13
  14. 14. Utilities□ Distributed Purified Water to Ph.Eur/ USP (18 pt loop)□ Centralised distributed gas system, N2, CO2, O2, Air and Mixed gas□ Central process alarm system, with alarm inputs in all production suites, linked to security system□ Temperature Monitoring□ Back up generator system available in all production suits□ Plant steam□ Full range of ancillary equipment on site including GMP and waste autoclaves, washers etc.27/03/13 14
  15. 15. GMP Suites Layout Cell Culture Suites DSP Suites Stairs Stairs Cell Culture DSP 2 Cell Culture 2 4o C 1 29m2 DSP 1 28.5m2 24m2 4o C 23m2 Lift Lift Cold Prep Store Lab. 8.6m2 7.5m2 EXIT EXIT Cold Cleaning/ Analytical Store Sterile Sterilisation Cell Culture Media / Lab. 21.5m2 Store 20m2 3 Buffer Prep. 31.5m2 DSP 3 18m2 23m2 Lab. 27m2 22m2 Corridors Class C Class D Lab. Class C (Class D) Production Anteroom Process Flow27/03/13 15
  16. 16. Other Space□ Long Term Client Dedicated purpose built GMP space□ GMP Cell Banking Area□ GMP Cell Storage Area□ GMP Microbiology Lab□ Development Labs□ Older lab & clean room space available for client projects long & short term□ Office Areas□ Conference Room27/03/13 16
  17. 17. Services: Quality Assurance □ Robust Quality System □ IMP Authorisation (IMB- 057) □ In House Qualified Person (QP) □ Successfully in all IMB (EMEA) Audits since 1998 □ Support for Regulatory Filings & Documentation for EMEA, FDA, ISO □ QA Department with  Validation  In House Microbiology  Environmental Monitoring27/03/13 17
  18. 18. Services: Cell Culture □ GMP Cell Banking & Storage □ CO2 Incubators/ Flasks/ Spinners/ Roller Bottles/Hollow Fibre □ Small Scale Process Development Bioreactors □ 10L wv Batch/Perfusion □ 100L wv Batch/Perfusion □ .25L to 50L Single Use ‘WAVE’ Bioreactor Batch/Perfusion □ SUB Disposable bioreactor 50 & 250L 2009 (Fed) Batch/Perfusion □ SUB to 1000L 2009 (Fed) Batch/Perfusion □ 3 independent cGMP Cell Culture Suites □ Media/Buffer Prep Lab □ Media Screening27/03/13 18
  19. 19. Services: Down Stream Processing □ Process Development □ GMP Purification □ 3 DSP rooms □ 2 rooms can operate 2 to 8oC □ Dedicated room per process □ Chromatography/Purification  GE Akta Explorer for development and small scale GMP  Millipore K-Prime for process scale  UFF/TFF etc.  Produced Commercial therapeutic r-glycoprotein (9 unit operations/5 column steps)27/03/13 19
  20. 20. Services: In Process Analytical □ UVA280 □ pH & Appearance □ SDS-PAGE (R) & SDS-PAGE (NR) □ IEF □ Endotoxin & Bioburden □ Mass Spec* □ HCP □ HPLC □ DNA □ Cell Based Bioassay* □ ELISA Assay Development □ TOC □ IEF-Western □ In Process Assays/Testing □ In House Microbiologist & Environmental Monitoring □ Method Development/Validation □ Final Release Testing with Partner * with contract research partner27/03/13 20
  21. 21. Services: Fill Finish □ Manual Fill capabilities □ Produce the penultimate API material □ Grade A cabinet in Grade C/D background □ Manual Labelling & Packaging27/03/13 21
  22. 22. Why BioUETIKON?□ Good People Skills & Experience□ Good Facility (Space & Layout)□ Good Location (Ireland has excellent compliance record for API manufacture & easy access US/EU)□ Quality System, QP, Audit record□ Local Contract Research Network□ Flexibility to Respond to Needs□ Financial Backing & Stability27/03/13 22
  23. 23. Marketing consideration• Target audience profile □ Start Up and Mid Size Biotech with funded clinical development pipeline/programs □ EU, Switzerland and US □ Innovator and biosimilar □ Many are ‘virtual’ organisations and outsource already ‘C’ level targets □ Very conservative, pay a premium to established players □ Long, detailed decision making process, ‘big’ decision □ High due diligence (site audit, formal suitability assessment) □ High regulatory compliance requirement• type of clients (current and prospects) □ International  UK start up, e.g. spin out from Cambridge Uni.  German biotech start up  US Cancer Institute  Dutch biotech start up etc.
  24. 24. Specific issues□ Limited Market Reputation as New company in CMO Development and GMP Space. How to get considered as a service provider?□ Visibility□ Coverage with limited resource□ Website –How could it improve? Interactive?□ Search engine optimisation – are we getting the most out of our Google Adwords?□ Technical Competence
  25. 25. Specific issues□ Conferences – how can we entice more people to our booth without spending a fortune?□ Our competitors – how can we stand out against Lonza, Cobra, Eden Biodesign, BioAlliance, Avid Bioservices, ProBioGen?□ Video any ideas about how this could be done using some of the footage already taken? May need to be reshot in the future – could they work with the DCU Communications Department?□ Tag line – do we need one? If so it should be simple yet effective e.g. “Supporting Biopharmaceutical Visions” – ProBioGen.□ Logo (does it represent honesty, integrity, professionalism?) Possible redesign. Should there be a positive emotional attachment to the logo?
  26. 26. To End□ Prize□ Questions?