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)


Available cell culture media do not meet the needs

The result is…

Development of proprietary cell culture media systems


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)


Problems with cell culture medium development

Outcome of your development is uncertain

• No success guaranteed

• No experience

• No data about scalability

• No stability data


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. ?


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!


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”


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


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


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5 L bioreactor – lab scale

01/03/2012 13

5 L bioreactor – lab scale


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


From 25 mL shake flask directly to 1000 L bioreactor

Source: Rentschler Biotechnologie GmbH


Data production process

Economical view

Media make up no more than 5% of your cost of goods

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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!

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Benefits of the Media System

• Easy scale up, saves time

• Minimizes risk, batch to batch conformity

• Media System shows high productivity

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What makes the difference to other Media Systems?

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+

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Innovative formulation

Excellent powder

production technology

ActiCHO System

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ActiCHO Media System

Thank you for your attention!

Eric Kurzhals

[email protected]

development of a cutting edge cho cell culture medium

Health & Medicine