Irvine CELLine Bioreactor Flask - page 5

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Company Profile
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Irvine Scientific Company Profile
Irvine Scientific, a member of JX Holdings group, is a worldwide leader in the design, manufacture and distribution of medical devices,
including Industrial Cell Culture, Cytogenetic, Assisted Reproductive Technology (ART) and Specialty Media products. Irvine Scientific is a
large scale producer of advanced quality cell culture media for the industrial bioprocess, medical, and diagnostic markets. The company’s
extensive experience in the design of culture media, compliance with ISO and FDA regulations for class II/III medical devices, and industrial
scale manufacturing capacity provides its customers with unique capabilities and support. Irvine Scientific delivers products worldwide to
biopharmaceutical industry, research and medical laboratory communities.
CONCLUSION
The experiment provided consistent results in the shake flasks and the CELLine bioreactor flasks. There was more yield using the BalanCD
CHO Growth A than the IS CHO-CD G10.7. The amount of labor required to operate the CELLine flask was higher than the shake flask but
the yield was much higher. The CELLine flask did not require any additional fixed equipment, such as shaking equipment. The purification
burden was lower for the CELLine flask as the total harvest volumes were 60mL and 20mL, over four harvests, that contained approximately
7g of IgG per Liter. The shake flask cultures had a single harvest at 36mL and 30mL with an average concentration of IgG of 2.1g per Liter.
One surprising result was the potential reduction in scale up time using the CELLine flasks. To operate a 1 Liter shake flask, four times the
amount of cells are required for initial seeding; approximately 90 million compared to 20 million required to seed a CELLine bioreactor flask.
This could potentially save 1-2 weeks in scale up time. Further studies need to be conducted to determine if the media needs to be refreshed
every 7 days or if the media can support cell growth for a longer period of time. This could potentially decrease the operational costs and
service requirements.
Bioreactor
Cost of Flask
Media Used
In 28 Days
14-Day Yield
(Grams)
28-Day Yield
(Grams)
CELLine 350
$160
1.4L / $116
0.08
0.16
CELLine 1000
$200
4L / $332
0.25
0.49
Price estimates are based on retail cost.
Input
CELLine 1000
Bioreactor, 14-Days
1L Shake Flask, 14-Day
Fed-Batch
Labor: Cell Culture
High: Media exchange and product harvest every 7 days Low: Minimum feed work
Media Cost Per 14-Day Culture
High: 2L @ $167
Low: 360mL @ $30
Purification Burden
Low: 30mL to purify
High: 360mL to purify
Equipment Required
Low: CO
2
incubator
High: Incubator, shaker platform
Scale Up Prior to Experiment
Low: 2.25 x 10
7
cells needed
High: 9 x 10
7
cells needed, larger seed train
The experiment also showed that the CELLine bioreactor flask size and run time can be selected based on required yield. This CELLine 1000 is 3 times the size of CELLine 350
and scales linearly.
Seeding And Harvesting Densities
CELLine 350
CELLine 1000
Preculture (Viable Cells)
7.5 x 10
6
22.5 x 10
6
Inoculation Volume (mL)
5
15
Inoculation Concentration (Viable Cells/mL)
1.5 x 10
6
1.5 x 10
6
Harvesting Concentration (Viable Cells/mL)
20-40 x 10
6
20-40 x 10
6
Titer (mg/mL)
1 - 10
1 - 10
Antibody Yield per Month (mg)
20-200
60-600
1,2,3,4 6
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