Development of a cutting edge CHO cell culture medium

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Development of a cutting edge CHO cell culture medium

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Development of a cutting edge CHO cell culture medium

  1. 1. Cell Culture World Congress 2012 Welcome to the Cellca company presentation DEVELOPMENT OF A CUTTING EDGE CHO CELL CULTURE MEDIUM Eric Kurzhals 29th of February 2012 Cellca GmbH I Erwin-Rentschler-Str. 21 I D-88471 Laupheim www.cellca.de
  2. 2. Typical features of cell culture media Process • Production medium is provided without feeds and feed pattern Composition • Unbalanced, poorly buffered, formation of metabolic waste products during process • Complex and expensive, usage of growth factors, serum or hydrolysates © Cellca presentation 01/03/2012 2
  3. 3. Characteristics of the cutting edge cell culture medium Process • Designed for the performance of high yield processes • Ready to use, commercially available and can be easily scaled-up Composition • Components are designed to fit perfectly together, less metabolic waste product formation (lactate) • All media parts are fully chemically defined (free of proteins, growth factors or hydolysates) © Cellca presentation 01/03/2012 3
  4. 4. Available cell culture media do not meet the needs The result is…  Development of proprietary cell culture media systems © Cellca presentation 01/03/2012 4
  5. 5. Problems with cell culture medium development Cell culture media development is expensive • Long development timelines • Large number of experiments required • Specialist with scientific knowledge • Stable high expression clone needed for development (prerequisite) © Cellca presentation 01/03/2012 5
  6. 6. Problems with cell culture medium development Outcome of your development is uncertain • No success guaranteed • No experience • No data about scalability • No stability data © Cellca presentation 01/03/2012 6
  7. 7. What is the solution for this dilemma? Only two options: 1. Accept mediocrity 2. Spend a lot of time and money for development of your own media system 3. ? © Cellca presentation 01/03/2012 7
  8. 8. What is the solution for this dilemma? There is a 3rd option available  Cellca and GE/PAA developed a cutting edge CHO cell culture media system for you! © Cellca presentation 01/03/2012 8
  9. 9. How did we do it? Composition and process science • Cellca GmbH has been working for the last 5 years on development of a perfect cell culture medium “more than 5000 single shake flask experiments” “more than 250 small scale bioreactor runs” © Cellca presentation 01/03/2012 9
  10. 10. How did we do it? Production experience and customer orientation • GE / PAA Laboratories GmbH has been working many years in this area  Largest set-up of powder mills in the Cell Culture Industry, powder media up to 8000 kg batch sizes  Two impact mills (same technology, same equipment type)  Traceability of raw materials (CoA, CoO) for each substance used for production of GMP powder media  Whole powder production strictly free of animal derived components © Cellca presentation 01/03/2012 10
  11. 11. Media System Components • Stock Culture Medium (SM): selective medium for adaptation of the cells, not rich in nutrients • Production Medium (P): non selective basal medium, rich in nutrients, used for the batch phase of the fed batch and any seed • Feeds (A and B): are added according to predetermined feeding protocols during the fed batch, rich in nutrients  all components are built on the same basis of raw materials  all components fit perfect together in the media system © Cellca presentation 01/03/2012 11
  12. 12. 5 L bioreactor – lab scale 01/03/2012 12
  13. 13. 5 L bioreactor – lab scale 01/03/2012 13
  14. 14. From research to cGMP production • Easy to scale • Easy to use • Powder formulation • Stable > 1 year • Easily soluble • Easily filterable • Easy preparation • No osmolality adjustment • No pH adjustment • Used in cGMP production © Cellca presentation 01/03/2012 14
  15. 15. From 25 mL shake flask directly to 1000 L bioreactor Source: Rentschler Biotechnologie GmbH © Cellca presentation 01/03/2012 15
  16. 16. Data production process © Cellca presentation 01/03/2012 16
  17. 17. Economical view Source: Andrew Sinclair, BioProcess International June 2010 http://www.bioprocessintl.com/multimedia/archive/00098/BPI_A_100806SUPAR03__98210a.pdf  Media make up no more than 5% of your cost of goods 01/03/2012 17
  18. 18. Economical view • Cost of Goods breakdown shows that media cost are no more than 5% of your total CoG • CoG = €/g • CoG = € x 1.05 / product x 1.10  5 % cost saving  if you improve the productivity of your process by only 10% or more doubling the media cost will still make economical sense! 01/03/2012 18
  19. 19. Benefits of the Media System • Easy scale up, saves time • Minimizes risk, batch to batch conformity • Media System shows high productivity 01/03/2012 19
  20. 20. What makes the difference to other Media Systems? Innovative formulation + + Excellent powder production technology = = ActiCHO System 01/03/2012 20
  21. 21. ActiCHO Media System Thank you for your attention! Eric Kurzhals e.kurzhals@cellca.de 01/03/2012 21

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