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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
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
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
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
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
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
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
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
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
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
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
5 L bioreactor – lab scale

01/03/2012

12
5 L bioreactor – lab scale

01/03/2012

13
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
From 25 mL shake flask directly to 1000 L bioreactor

Source: Rentschler Biotechnologie GmbH

© Cellca presentation

01/03/2012

15
Data production process

© Cellca presentation

01/03/2012

16
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
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
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
What makes the difference to other Media Systems?

Innovative formulation
+

+
Excellent powder
production technology

=

=

ActiCHO System

01/03/2012

20
ActiCHO Media System

Thank you for your attention!
Eric Kurzhals
e.kurzhals@cellca.de

01/03/2012

21

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Development of a cutting edge CHO cell culture medium

  • 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 5 L bioreactor – lab scale 01/03/2012 12
  • 13. 5 L bioreactor – lab scale 01/03/2012 13
  • 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. From 25 mL shake flask directly to 1000 L bioreactor Source: Rentschler Biotechnologie GmbH © Cellca presentation 01/03/2012 15
  • 16. Data production process © Cellca presentation 01/03/2012 16
  • 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. 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. 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. What makes the difference to other Media Systems? Innovative formulation + + Excellent powder production technology = = ActiCHO System 01/03/2012 20
  • 21. ActiCHO Media System Thank you for your attention! Eric Kurzhals e.kurzhals@cellca.de 01/03/2012 21