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Please complete this form electronically, print, sign and forward with your sample

BIOSAFETY TESTING:
ARTICLE SAMPLE SUBMISSION FORM
BRL TA NUMBER
Please complete this form electronically and in English (sections 1-5 & 13-14 are mandatory). Please
print, sign and date the completed submission and submit to BioReliance with your sample(s).

1. Authorised Representative Details
2. Billing Representative Details
Address 1
Address 1
Address 2
Address 2
ZIP/Postcode
ZIP/Postcode
Telephone
Telephone
Required test
Contract /
final report date
Quote Number
(for info only)
PO Number
3. Test Article (TA) information
Test Article sample type
e.g: cel bank, bulk harvest etc.
Test Article Species of Origin (e.g., Human)
Test Article Designation
(this is the information which wil appear on your
Final Report(s))
Is the test article a re-submission
YES / NO
If yes, please provide BRL TA Number:
Has the test article been genetically modified?
YES / NO
If yes please complete & send the GMO form PB0054 to the
PM in advance of sample send (UK safety requirement)
YES / NO
Cell growth required?
If yes please complete & attach form PB0055 Does the test article contain antibiotics?
YES / NO
If yes, Antibiotic:
By submitting this completed form to BioReliance it is understood that the sponsor accepts responsibility for the completeness and advisability of the studies. Services to be provided shal in al respects be subject to and governed by the terms and conditions of BioReliance.
BIOSAFETY TESTING:
ARTICLE SAMPLE SUBMISSION FORM
BRL TA NUMBER
Is the Sample Cytotoxic? (or is in the presence of YES / NO
cytotoxic reagents such as pluronic acid, Number of cells/ml in test article
(if applicable)

Is the sample viral in nature?
YES / NO
If yes, specify: LIVE / INACTIVATED / ATTENUATED
Biosafety Level (e.g., BSL1, BSL2, BSL3) and
Attachments: Safety Assessment / MSDS / not available Is the test article known/suspected to be
contaminated with infectious
microorganisms / viruses (e.g.
mycoplasma, retrovirus, bacteria)

By submitting this completed form to BioReliance it is understood that the sponsor accepts responsibility for the completeness and advisability of the studies. Services to be provided shal in al respects be subject to and governed by the terms and conditions of BioReliance.
BIOSAFETY TESTING:
ARTICLE SAMPLE SUBMISSION FORM
BRL TA NUMBER
Please provide the Project or drug or product name
for this TA (for info only).
Provide additional instructions (i.e.,
sample dilution requirements and diluent (specify)
additional material like media and antisera (specify).
pooling samplesspecific neutralisation conditions • Specific positive control (specify, e.g. host microbial host growth media and optimal growth supernatant (i.e. for infectivity assays) what volume should be inoculated (please provide sufficient for this plus spike) specify how many cel s make up 1% of the bank. If frozen vial submitted, please provide > 1% as viability will be < 100% 4. Testing Requested
Protocol Number
Volume of Test
Physical Description
Storage conditions on
Article provided
receipt (circle as
applicable)

37± 2°C
(15 - 30°C)
Room Temperature
(15-25oC)
-15 to -40°C
Liquid Nitrogen
By submitting this completed form to BioReliance it is understood that the sponsor accepts responsibility for the completeness and advisability of the studies. Services to be provided shal in al respects be subject to and governed by the terms and conditions of BioReliance.
BIOSAFETY TESTING:
ARTICLE SAMPLE SUBMISSION FORM
BRL TA NUMBER
5. Compliance Requirements
Please specify regulatory requirement for testing.
Tick as applicable
Support the release of a licensed product Support the release of a clinical material 1. GLP study (specifical y laid down in a national legislation? 2. GLP study (requested by receiving authority (e.g., FDA), provide details and identify the receiving authority supporting the request) 3. GLP Study (require work that does not constitute a ful GLP study but wil be used to support a ful study) If any of the following assays are to be performed then please complete each section as
applicable:

6. IN VITRO ASSAY for the Presence of Viral Contaminants
MRC-5 (human diploid lung cells) and Vero (African green monkey kidney cells) will be used. One or
more additional indicator cells may be used. Please tick which additional cell line you require (this
should be the same species of origin as the test article)

Cell type
Tick if applicable
By submitting this completed form to BioReliance it is understood that the sponsor accepts responsibility for the completeness and advisability of the studies. Services to be provided shal in al respects be subject to and governed by the terms and conditions of BioReliance.
BIOSAFETY TESTING:
ARTICLE SAMPLE SUBMISSION FORM
BRL TA NUMBER
7. RCA (37151 or 031202)
How many viral particles do you require us to test What is the titre of the TA 3 separate vials are required for the study. 8. Cocults (37061,64xxxx, 76xxxx, 77xxxx, 011608, 619xxx, 620xxx, 622xxx, 624xxx, 630xxx , 824xxx)
Please confirm if inoculation from frozen or live culture 9. F-PERT(protocols 107405, 37405) and Q-PERT (protocols 33112 and 107320) assays
A pre-purification step performed at the time of harvest can in some instances decrease the amount of DNA
polymerase activity. At harvest we recommend a slow centrifugation of 3,000 to 12,000 rpm (up to 17,000 x g)
for 10 minutes at 5oC ± 3°C (if this is not possible, room temperature wil suffice). The sample should be
filtered through a 0.45 µm filter and the supernatant frozen and shipped as the test article.
Tick if this has been performed
10. Residual DNA assays (107019, 33019)
The nature of the residual DNA to be quantified must be supplied. Please select the target of interest below.
Residual DNA
Tick if applicable
By submitting this completed form to BioReliance it is understood that the sponsor accepts responsibility for the completeness and advisability of the studies. Services to be provided shal in al respects be subject to and governed by the terms and conditions of BioReliance.
BIOSAFETY TESTING:
ARTICLE SAMPLE SUBMISSION FORM
BRL TA NUMBER
11. Restriction enzyme Digestion/Gene Copy number
DNA sequence in electronic format (Word or text file) DNA sequence in electronic format containing restriction enzyme sites
Appropriate restriction enzyme sites and expected size in
base pairs
Plasmid positive controls absolute requirement for
Please tick if plasmid is included in
testing - Please supply a minimum of 50ug of plasmid
shipment
Please document the plasmid size and supply
Please tick if data is attached
restriction map with the gene of interest
Specific Hybridisation Conditions (if applicable) -
Please tick if information is attached
Please supply any specific hybridisation/wash conditions 12. Sequence analysis of extranuclear recombinant expression vectors.
DNA sequence in electronic format (Word or text file) Specify coordinates for analysis (i.e., coding sequence from x nucleotide to y nucleotide).
Host Strain Plasmid copy number (e.g., High or Low)Antibiotic resistance / selective agent and concentration for useGrowth media and conditions 13. It is BioReliance standard policy that 30 days after the issuance of final invoice(s), any
remaining original TA/samples/cel s will be discarded. Please inform us if you would like any
unused test article to be returned to you at your own cost
(please confirm in box provided)
14. Please sign and date the completed printed form.
Signature of Authorised Representative
By submitting this completed form to BioReliance it is understood that the sponsor accepts responsibility for the completeness and advisability of the studies. Services to be provided shal in al respects be subject to and governed by the terms and conditions of BioReliance.

Source: http://www.bioreliance.co.jp/assets/DownloadableForms&ConditionsPDFs/PB0051R01SampleSubmissionForm1.pdf

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