Downstream 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. Experimental Details
a. General Details
1.
The target molecule to be purified
2.
Size or M
r
of target molecule
3.
NaCl/pH/T ranges T: T: within which the target molecule is stable
NaCl
T
pH
4.
Is the standard (purified target molecule) available?
Yes
No
5.
Typical concentration of the target molecule (titer in the case of virus) in the sample that will be provided for the method/ process development
6.
Main impurities in the sample (Specify concentrations of each)
DNA
Lipids
Proteins
Endotoxins
Others
7.
Sample volume/total virus titer is available for the method development
8.
Current detection/ quantification method for the target molecule
DNA/protein assays
ELISA
SDS PAGE
Western blot
qPCR
Cell-based assays
Others
9.
Desired concentration of the target molecule in the final product
Concentration:
Unit of measurement:
mg/ml
infection VP/ml
total VP/ml
Others
10.
Purity requirements of the final product (Host cell protein/DNA concentration, endotoxin content…)
11.
Final formulation buffer
12.
Other requirements regarding the method/ process to be developed
13.
Please describe upstream and downstream process detail or block scheme
II. Experimental Details
b. Virus Products (Skip if not applicable)
14.
Virus condition needed
Live
Killed
Attenuated
15.
Virus Type
Wild type strain
GMO
16.
For GMO virus, please provide the detailed data/ document descriabing preparation of the GMO. (e.g., constructs, vectors, expression system used…)
17.
What is the biosafety level of this virus? If safety assessment study is available, please provide the documentation.
