Upstream BioProcessing Questionnaire
Please answer the following questions as completely as possible.
I. Customer Information
Contact Person
Company Name
Designation
Contact Number
Department
Email Address
II. General Details
1.
Target Product
Secreted Protein
Non secreted protein
Cell Bank
mAbs
Cell Therapy
Virus Production
Yes
No
Cultivated Meat
Others
2.
Cell Type
Adherent cell (Proceed to Adherent Cell Questionnaire)
Suspension cell (Proceed to Suspension Cell Questionnaire)
3.
What process development (PD)/optimization do you require?
Cell line development
Upstream development
e.g. bioreactor media optimization, harvest protocol
Downstream development
e.g. optimization of platform DS process
No PD required. Process to be transferred at existing scale to manufacturing.
4.
Do you require any of the following? Please attach an extra sheet if additional services are required
Analytical Method Validation
cGMP manufacturing and lot release
Stability testing
Sterility testing of final product
Adventitious virus testing
Others
Adherent Cells Questionnaire
III. Experiment Details
a. General Details
1.
Cell Line
CHO
Vero
Hybridoma
MDCK
HEK 293
SF-9
Others
2.
Any special features or peculiarities of the cell line or methods
3.
Intended Use
Human Use
Animal Use
4.
Current Culture System
T-flask:
Pcs
Cell stack:
Pcs
Roller bottle:
Pcs
Hyper flask:
Pcs
Spinner flask:
Pcs
Stirred Tank Bioreactor with Carriers:
Pcs
Cell factory:
Pcs
Others:
Indicate Capacity in liters (L):
5.
If carriers are used, please specify type and amount of carrier.
Microbeads, Specify:
Fibrous matrices, Specify:
Others, Specify:
Amount of carriers:
grams
6.
Culture condition for cell growth
Media
Serum
Temperature
7.
Currently using serum-free culture medium?
Yes
No
8.
Concentration of additives
Sodium Bicarbonate
Hepes Buffer
Others
9.
Cell Harvesting Required
Yes
No
10.
Use of trypsin during cell harvest
Yes
No
Use others. Please specify:
11.
Cell Quantification
Manual counting
Nuclei counting
Auto-counter
Others
12.
Access to a bio-analyzer for measuring glucose, lactate, glutamine, etc.
Yes
No
13.
System preference
Single-Use Preference
No Preference
Multiple-Use Preference
14.
Scale-up plan in terms of number of cells
10
9
10
11
>10
13
10
10
10
12
15.
Scale-up plan in terms of volume
50L
100L
500L
Others. Please specify:
b. Protein Production
1.
Culture period prior to harvesting
3 Days
5 Days
7 Days
Others, (Please Specify): days
2.
Protein extraction method
By cell harvest
By medium harvest
Freeze/Thaw method
Others
c. Cell Therapy
1.
Target
Autologous Cell Therapy
Allogeneic Cell Therapy
Research Use
Others
2.
Cell Source
Bone Marrow
Adipose-derived
iPS
Embryo
Placenta
Umbilical
Dermal fibroblast
Others
d. Virus Production
1.
Virus Type/Strain
Secreted Virus
Non-secreted Virus Virus
Strain:
2.
Please describe the Virus Strain? (ds, ssDNA,ds,+/- ssRNA, enveloped, nonenveloped, temperature sensitivity, etc.)
3.
Cell density prior to infection in current culture system
4.
Multiplicity of Infection (MOI)
5.
Period of time for cell lysis to occur after infection in current culture system
6.
Culture condition post infection
Media
Serum
Temperature
7.
Best phase for infection
Right after seeding
Plateau phase
Exponential phase
8.
Is the virus stable during post infection?
9.
Virus titer in current culture system (dose/ml)
10.
Best time to harvest the virus
11.
Is there CPE (cytopathic effect) after infection? When?
Yes, Please specify:
No
12.
What kind of CPE is formed (e.g. syncytium, destruction, etc.)
13.
Cell lysis post infection
Yes, Please specify:
No
14.
Number of harvests that could be done during post infection period
Single Harvest
Multi-harvest for
times
Continuous Harvest for
days
15.
Do cells keep propagating after virus infection?
Yes. Indicate fold increase post infection:
No
16.
For virus production, annual manufactured dose
