3. www.applikonbio.comSlide 3
Bioprocessing has traditionally been at larger culture
volumes
ManufacturingProcess Development and Scale UpUpstream Research
• Bioreactor operation
• Seed culture manipulation
• Harvest and downstream purification
• Equipment
• Data analysis
• Experimental design
• Regulatory requirements
• cGMP protocols
• Industrial safety
4. www.applikonbio.comSlide 4
Consider early development screening...
• Early stage "winners" can lock in the route of
development work during scale up to production
10,000 1,000 150 25
“Winners”
≠Unfortunately,
5. www.applikonbio.comSlide 5
Trend toward greater bioprocessing examination,
sooner.
ManufacturingProcess Development and Scale UpUpstream Research
NumberofCultures
# of Cultures Cost / Culture Process Information
CostperCulture
6. www.applikonbio.comSlide 6
Trend toward greater bioprocessing
examination, sooner.
ManufacturingProcess Development and Scale UpUpstream Research
NumberofCultures
# of Cultures Cost / Culture Process Information
CostperCulture
Acquiring process
data sooner.
7. www.applikonbio.comSlide 7
Trend toward greater bioprocessing
examination, sooner.
ManufacturingProcess Development and Scale UpUpstream Research
NumberofCultures
# of Cultures Cost / Culture Process Information
CostperCulture
Reducing cost of early
development.
Acquiring process
data sooner.
9. www.applikonbio.comSlide 9
New technology for bioprocessing at small scales:
Sensor Shake Flasks
OD Readers
Sensor Dishes
RAMbio
Mini Bioreactors
Parallel Off-Gas
Well Plates
Process Optimization:
Bioreactor Experiments
Process Definition:
Well Plates,
Flask Characterization
Strain Construction:
Tubes, Well Plates
Flasks, Shakers
Identification:
Cloning, Fluorescence, W
ell Plates, Flasks
Process DevelopmentScreeningSelectionResearch
Classic
Autoclavables
10. www.applikonbio.comSlide 10
• Bioprocessing principles in upstream research
• Bioreactor startup and operation
• Bioreactor control & typical parameters
• Culture modes (batch, fed-batch, continuous)
• Culture kinetics (growth, nutrient uptake, product formation)
• Bioengineering basics (gas transfer, mixing)
• Understanding the abilities and limitations of small-scale tools
• Small bioreactors vs. large one
• Artifacts of microtiter plates
• Advantages/Disadvantages of scaling down
• Data analysis and statistics - and communicating these data