Development of a cutting edge CHO cell culture medium
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Transcript of Development of a cutting edge CHO cell culture medium
Welcome to the Cellca company presentation
www.cellca.de
Cellca GmbH I Erwin-Rentschler-Str. 21 I D-88471
Laupheim
Cell Culture World Congress 2012
DEVELOPMENT OF A CUTTING EDGE CHO CELL CULTURE MEDIUM
Eric Kurzhals
29th of February 2012
© Cellca presentation 01/03/2012 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
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
01/03/2012 12
5 L bioreactor – lab scale
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5 L bioreactor – lab scale
© Cellca presentation 01/03/2012 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 15
From 25 mL shake flask directly to 1000 L bioreactor
Source: Rentschler Biotechnologie GmbH
© Cellca presentation 01/03/2012 16
Data production process
Economical view
Media make up no more than 5% of your cost of goods
01/03/2012 17
Source: Andrew Sinclair, BioProcess International June 2010
http://www.bioprocessintl.com/multimedia/archive/00098/BPI_A_100806SUPAR03__98210a.pdf
01/03/2012 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 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 20
What makes the difference to other Media Systems?
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Innovative formulation
Excellent powder
production technology
ActiCHO System
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