Download questionnaire a - Waisman Biomanufacturing

Questionnaire for Plasmid DNA Production Services
When finished, please email reply to:
Brian Dattilo
Manager of Business Development
Waisman Biomanufacturing
Email: [email protected]
Today’s Date
Principal Investigator or
Client
Company or Institution
Product Name
Services Requested
Assay Development
Cell Banking
cGMP Manufacture
Aseptic Fill
Quantity of plasmid desired
(mg or g)
What agency will this
product be regulated by?
Date Desired
FDA
EMEA
Other
1. How did you hear about Waisman Biomanufacturing?
2. Product and Intended Use
a. Gene Product
Please briefly describe the identity of your gene product.
b. What is the plasmid backbone?
pUC
pBR322
Other
c. This product is intended for use in (check all that apply):
Research only and not for use in animals or humans
Animal /tox studies
Human clinical trials:
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Questionnaire for Plasmid DNA Production Services
Phase I
Phase II
Phase III
d. What is the intended use/grade of plasmid requested?
Use in manufacturing processes such as viral vector production
Ex-vivo use as a gene therapy (e.g. modified T-cells)
Direct injection grade for vaccine or gene therapy
e. What indication is this product for?
3. Safety Information
a. Does the transgene produce a select agent?
Yes
No
b. What biosafety level is the plasmid and expressed protein?
BSL-1
BSL-2
BSL-3
4. Manufacturing Information
a. Vector Information
Please describe your vector including overall size of plasmid, identity and size of gene, source of
gene, promoters, enhancers, selection marker, etc. Include a copy of the vector map if
available. Note - β-lactam antibiotics may not be used for cGMP production of injection grade
or large scale ex vivo/bioprocess grade (e.g. ≥ 200mg).
b. Product Quality - please indicate desired product quality control testing
(Specifications represent a recommended starting point for new plasmid projects. Results are typically much better for
standard pUC-based plasmids with transgenes that don't cause cell toxicity. Typically specifications are set broad
initially and then narrowed as plasmid characteristics in the process are established. Tighter specifications may be
requested for prophylactic vaccine indications (e.g. ≤ 1% host impurities). However, additional process qualification
trials and process development work may be required. An estimate of the additional work (time, materials) will be
included in the initial budget estimate if tighter specifications are requested.)
Test
Visual
pH
Identity
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Methods / Comments
pH meter
Restriction digest and
AGE
Typical Starting
Specification
Clear/colorless
Report result
Conforms to reference
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Requested Specification
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Questionnaire for Plasmid DNA Production Services
Test
Plasmid Size
DNA
concentration
A260/280 ratio
Percent
supercoiled
E.coli DNA
Residual RNA
Residual Protein
Endotoxin
Sterility
Potency
Methods / Comments
AGE on uncut plasmid
Absorbance at 260nm
Typical Starting
Specification
Conforms to reference
Absorbance at
260/280nm
HPLC
1.7 – 2.0
Quantitative PCR
HPLC
BCA
LAL
21 CFR 610.11
Bioactivity Assay
(performed by
Customer or can be
transferred to
Waisman)
≤ 5%
≤ 5%
≤ 5%
≤ 40 EU/mg
Sterile
TBD
Requested Specification
≥ 80%
Describe activity assay or any other assays that need development here, if necessary. Will these be
performed by Customer or transferred to Waisman?
c. What will you be providing as starting material?
cGMP Master Cell Bank
Research Cell Bank
Plasmid DNA
Other
d. Waisman recommends using either DH5-α or DH-10B strains of E. coli for producing plasmid
DNA. Please indicate if your cell bank is different or would prefer using an alternative bacterium
or strain of E. coli.
e. If applicable:
Please describe cell bank you are providing (e.g. bacterial strain, cGMP, research,
growth/expression, purity, etc.).
Please describe testing on plasmid (e.g. fully sequenced GLP/GMP-grade?), insert sequenced,
copy number, etc.). Was this plasmid previously produced by your group or others?
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Questionnaire for Plasmid DNA Production Services
Please describe knowledge of fermentation plasmid productivity (scale, mg/L).
Please provide any information regarding plasmid stability in fermentation.
5. Master Cell Bank
a. If not provided, how large of a bank is needed (200-300 vial is typical)?
b. Cell Bank Testing – The table below lists standard Master Cell Bank testing.
Please indicate any additional tests you would like below. Please note that nonstandard testing
may incur extra cost for development or sourcing.
Test
Description
Growth Characteristics
Report cell counts and growth characteristics
Culture purity
Plate out culture, gram stain, examine morphology and for presence
of bacterial or fungal contaminants
Identity
Tests conducted to confirm correct host
Bacteriophage
Test for the presence of bacteriophage (this must be done prior to
entry into the cleanroom)
Antibiotic
Resistance
Demonstrate appropriate antibiotic resistance to verify retention of
plasmid
Restriction Digest/AGE
Verify correct plasmid. Perform prior to sending out for sequencing
Plasmid Sequence
Sequence entire plasmid for FDA submission
6. Fill / Finish
If fill / finish is required, how many vials and at what DNA concentration?
Waisman uses WFI or TE as a standard plasmid solution. Is there a specific formulation for your
plasmid, or is WFI or TE acceptable?
7. Please provide any other information or clarification
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