Stem Cell Culture Questionnaire
Please answer the following questions as completely as possible.
I. Customer Information
Contact Person
Company Name
Designation
Contact Number
Department
Email Address
II. Experiment Details
a. General Details
1.
Target
Autologous Cell Therapy
Allogeneic Cell Therapy
Subsidiary Products; Specify:
Research
Others
2.
Cell Source
Bone Marrow-derived
Placenta
Adipose-derived
iPSC
Umbilical Cord-derived
Amniotic fluid
Embryo
Others
b. Current Cell Culture
1.
Cell Line description (Any special features regarding the cell line or culture methods?)
2.
Intended Use
Human Use (Production)
Human Use (Research)
Animal Use (Production)
Animal Use (Research)
Others
3.
Current Culture System (Device used per production batch)
T-flask:
cm
2
x
Pcs
Petri Dish:
mm x
Pcs
Roller Bottle:
cm
2
Btls
Spinner flask:
mL x
Btls
Carriers:
Cell Factory / Cell Stack (Multi-layer):
(total surface area)
cm
2
x
Pcs
Stirred-tank Bioreactor:
mL x
Vessel
Carriers:
Others
4.
Average Cell Densities from current system (per culture using a single system e.g. per 1 roller bottle)
Seeding Cell Density
cells/cm
2
or
cells/mL
Harvesting End Cell Density:
cells/cm
2
or
cells/mL
Average culture duration:
days
5.
If carriers are used, please specify type and amount of carrier.
Microbeads, Specify:
Fibrous matrices, Specify:
Others, Specify:
Amount of carriers:
6.
Additional coating reagent for current system?
None
Gelatin
Fibronectin
Collagen
Others
7.
Media Volume Capacity
Working Volume Capacity;
mL / Pc (or /Btl)
Total Media Volume (start to end of culture)
mL / Pc (or /Btl)
8.
Medium exchange frequency for current system
24 hours (1 day)
48 hours (2 days)
72 hours (3 days)
Others
hours (
days)
Media volume per change:
mL
9.
Culture condition during cell culture
Base Media
Serum (type and %)
Temperature
CO
2
concentration of incubator
10.
Oxygen Control
Normoxia:
% O
2
Hypoxia:
% O
2
No Specific control
Others:
11.
Concentration of additives
Sodium Bicarbonate:
HEPES Buffer:
Others
12.
Glucose Concentration in initial culture medium
g/L
13.
Cell Harvesting (Cell Dissociation) required
Yes
No
14.
Cell Harvest (Cell Dissociation) enzyme used
Trypsin
TrypLE Express
TrypLE Select
Accumax
Accutase
Collagenase:
Others:
15.
Access to a bio-analyzer for measuring glucose, lactate, glutamine, etc.
Yes
No
c. Process Plan
1.
Scale up plan
Yes
No
2.
Scale-up plan in terms of number of cells
10
9
10
10
10
11
10
12
>10
13
3.
System preference
Single-Use Preference
Multiple-Use Preference
No Preference
Hybrid (both single- and multiple- use components in 1 culture system)
4.
Cell culture mode
Batch
Recirculation
Fed-batch
No Preference
Others
5.
Cell Quantification
Manual Counting
Nuclei Counting
Auto-counter
Others
6.
Do you prefer aseptic cell culture process? (System inside isolator)
Yes
No
Adherent Cells Questionnaire
II. Experiment Details
d. CelCradle
®
System
1.
Would seeding of 2 x 10
7
cells be difficult?
Yes
No
2.a
Will the CO
2
incubator be exclusively used for the CelCradle
®
system?
Yes
No
2.b
Is the CO
2
concentration adjustable?
Yes
No
