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Cell line development services

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Informative presentation about Cellca Cell Line Development Services.

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Cell line development services

  1. 1. Sartorius Stedim Cellca Custom Cell Line & Process Development for Pharmaceutical Purposes May 2017
  2. 2. Overview of Contents 2 Cellca History Overview: Cellca Technology Platform 3 4 Products & Services 2 Key Parameters: Why Cellca? 1 5 Contact Information
  3. 3. Cellca History 3 2012- 2015 2015 2005- 2010 2010- 2012 • Founded by Dr. Cayli • Focus: R&D, integrate molecular & cellular biology with process know- how • Product Development • Building Infrastructure • First technology transfer • Growing the company & customer base • Completed 48 projects • Improving the platform & performance • Growing internationally as a part of Sartorius group
  4. 4. Overview: Cellca Technology Platform 4 Host cell line Expression Vector Upstream Process Design Media System Host Cell Line: CHO DG44 growth in suspension, 18 h doubling time, long term stability Expression Vector: DHFR selection system, low DHFR expression, S/MAR elements, optimal signal peptide Media System: Optimized, chemically defined, free of animal components, proteins & peptones, high cell densities, viabilities & productivity Upstream Process Design: robust, easy to scale, proven performance in various bioreactor systems Cellca Cell Line Development Process Transfer GMP Production Downstream Processing Fill & Finish Process Development CMO/Client
  5. 5. Products & Services 5  FEE FOR SERVICE Our service is divided into individual work packages starting from DNA synthesis to RCB generation, stability studies, or process confirmation in lab-scale bioreactors.  TECHNOLOGY PLATFORM LICENSING Technology transfer to enable in-house generation of high producing cell lines  MEDIA SUPPLY All parts of the media system are completely chemically defined and optimized for the different stages. They are commercially available.
  6. 6. Key Parameters: Why Cellca? 6 Speed Performance Customer Focus Track Record Scalability
  7. 7. 7  From DNA to RCB within 4-5 months.  No need for media and process development. Save up to 3 months by omitting scalability studies! Speed Vector Cloning Transfection and Pool Generation Single Cell Cloning Clone Evaluation RCB Preparation From DNA to RCB in 4 to 5 months
  8. 8. 8 Scalability  Cellca technology platform was developed from scratch specifically for the industrial production  Focused development at Cellca lead to a process providing: Direct and robust scale-up to production scale No need for scalability studies
  9. 9. 9 Scalability 0.0 0.5 1.0 1.5 2.0 2.5 3.0 3.5 4.0 4.5 5.0 0 50 100 150 200 250 0 1 2 3 4 5 6 7 8 9 10 11 12 Productconc.[g/L] ViableCellConc.[105/mL] Viability[%] Time [ d ] Comparison VCC, Viability, Product conc. - 25-mL, 5-L & 1000-L SF 25-mL VCC BIR 5-L VCC SUB 1000-L Xcellerex VCC SF 25-mL Viability BIR 5-L Viability SUB 1000-L Xcellerex Viability SF 25-mL Product BIR 5-L Product SUB 1000-L Xcellerex Product VCC Viability Viability
  10. 10. 10 Performance: Titer  Efficient cost reduction by achieving steadily productivities of 3g/L or more  Cost reduced by 50% by omitting media and process optimization 0 100 200 300 400 500 600 700 800 900 1 2 3 4 5 6 7 8 9 10 Cost of Goods €/g Clone distribution Cellca* 95%; ≥ 3 g/L
  11. 11. 11 Performance: Quality  Targeted modification of quality attributes (e.g. glycosylation pattern)  Application for biosimilars  Scalability of modifications
  12. 12. Cellca Track Record (March 2016) 12 >40 cell lines built to date  Small, Medium and Big Pharma  US, EU, Asia Customers  60% returning customers 95% express 3 g/L or more  Monoclonal Antibodies (IgG1, IgG4, IgG2)  Fusion Proteins  Fab-related products  Bispecifics  Biosimilars Applications:  NBE  Biosimilar projects  Replacement E. coli  Productivity Improvement Track Record 2 g/L 3 g/L 4 g/L 5 g/L 6 g/L Pre-clinic & Phase 1 4 21 9 4 2 Phase 2 1 1 - - 1 Phase 3 1 - - - - Market Approval - - - - -
  13. 13. 13 Detailed Discussions F2F, TCs Agreement by both sides Final proposal SLA PROJECT: Committed project team & close contact with Customer Order Manager: Renate Westner Alexander Pietschmann Heike Mayer (Head of Team) Customer Focus Kick Off Data Packages Regular TCs Scope changes possible Final report PROPOSAL: Direct service and support by Product Management Team: Adelheid Burkhardt Dr. Lucia Rieger
  14. 14. Benefits of Cellca Technology Platform  SPEED From DNA to high-titre RCB in 4-6 months. Save up to 3 months by omitting the need for scalability studies.  SCALABILITY Processes can be easily transferred and scaled-up to a range of bioreactors up to 1000L.  PERFORMANCE 95 % of our developed cell lines deliver protein titres exceeding 3 g/L in a 12-14 day standard fed-batch process.  TRACK RECORD More than 40 successfully completed projects using the Cellca CHO Expression Platform.  CUSTOMER FOCUS Committed project teams and dedicated client manager’s make it their purpose to deliver service excellence and meet our clients requirements.
  15. 15. For more information on Sartorius Stedim Cellca’s Cell Line Development services: Contact us at www.biooutsource.com/contact-us/

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