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FOR WUXI APPTEC USE ONLY Sample Number and Technician Initials/Date: |
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PAYMENT METHOD (required) |
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QUOTE NUMBER (QUO ##### - ###### - #)
QUO - - - |
CLIENT INFORMATION |
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Account Number (required): |
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COMPANY NAME & ADDRESS   *EDITED* (Address for final report shipment)
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CONTACT FOR FINAL REPORT: |
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PHONE: |
EMAIL: |
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SECONDARY CONTACT (if applicable/needed): |
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PHONE: |
EMAIL: |
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If this is submission of additional material, check here:
Provide original WuXi AppTec sample reference #: |
NOTE: Do not use this form for more than one lot and/or type of sample. A separate completed form is required for each lot and/or sample type.
SAMPLE INFORMATION |
SAMPLE TYPE: Test Supply |
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Sample Designation as Labeled on Vessel
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General Description of Sample
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Sample Designation to be Used on Report (exact wording) |
Species of Origin |
Biosafety Level |
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Has the test article been validated by WuXi AppTec? Yes No Provide WuXi AppTec Qualification/Validation Protocol Number(s):
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CODE, BATCH, OR LOT NUMBER:
Specify: EXPIRATION DATE:
Specify: |
Commercial/Marketed Product? Yes No |
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For GLP studies (required by US FDA)
TEST ARTICLE CHARACTERIZATION
Sponsor affirms test article has been characterized or that characterization testing is planned. Sponsor confirms responsibility to retain proof of characterization. Sponsor affirms test article has been characterized and characterization information is included.
Sponsor is solely responsible for all test article characterization data as required in Good Laboratory Practices (GLP) regulations (21CFR58) Section 58.105 – identity, strength, stability, purity, and chemical composition. Methods of synthesis, fabrication, or derivation of the test articles shall be documented by the Sponsor. Sponsor is also responsible for ensuring that test article here submitted is representative of the final product that will be subjected to materials characterization. |
SAMPLE SHIPMENT & STORAGE |
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Sample Shipment Temperature
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Controlled Storage Temperature at WuXi AppTec
Cells submitted for expansion NOTE: For virology testing, sample storage conditions will be determined by the Study Director. |
Do not freeze/thaw
May freeze/thaw
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Upon test completion, samples to be:
Returned (Additional fee applies)
Provide courier company and acct. # for shipping:
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For GLP Testing: Part 58 of the Code of Federal Regulations (CFR), which describes the requirements for Good Laboratory Practice (GLP) for Non Clinical Laboratory Studies, states in section 58.105, part (d), that “For studies of more than 4 weeks duration, reserve samples from each batch of test and control articles shall be retained for the period of time provided by 58.195.” Please provide one additional sample per batch of test and control article for WuXi AppTec to retain. If you are unable to supply the additional sample, it will be noted in the Final Report. |
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SAMPLE PREP & HANDLING INSTRUCTIONS |
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N.A. |
Include pre-testing information such as dilutions, reconstitution, etc., and sample matrix or buffer components (if applicable)
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FORM-00564 |
WuXi |
• Page 1 of 3 |
Revision:07 |
TESTING TO BE CONDUCTED: |
GLP Non-GLP GMP |
REQUESTED TESTING |
STAT TESTING: Some assays are eligible for STAT processing. If a requested assay
is eligible, a "STAT"
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NOTE: Enter the Project Code from your Cell Therapy/Gene Therapy/Viral Vector Work Order before completing the remainder of the Requested Testing section. |
PROJECT CODE |
PROJECT NAME |
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TEST CODE |
TEST NAME |
Placeholder |
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Protocol Version #: XX • Effective Date: xx/xx/xx |
Sample Allocation (e.g., 1x1mL, 3x5mL) |
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STAT
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Placeholder |
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Protocol Version #: XX • Effective Date: xx/xx/xx |
Sample Allocation (e.g., 1x1mL, 3x5mL) |
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STAT
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Placeholder |
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Protocol Version #: XX • Effective Date: xx/xx/xx |
Sample Allocation (e.g., 1x1mL, 3x5mL) |
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STAT
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Placeholder |
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Protocol Version #: XX • Effective Date: xx/xx/xx |
Sample Allocation (e.g., 1x1mL, 3x5mL) |
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STAT
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Placeholder |
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Protocol Version #: XX • Effective Date: xx/xx/xx |
Sample Allocation (e.g., 1x1mL, 3x5mL) |
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STAT
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Placeholder |
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Protocol Version #: XX • Effective Date: xx/xx/xx |
Sample Allocation (e.g., 1x1mL, 3x5mL) |
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STAT
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Placeholder |
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Protocol Version #: XX • Effective Date: xx/xx/xx |
Sample Allocation (e.g., 1x1mL, 3x5mL) |
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STAT
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Placeholder |
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Protocol Version #: XX • Effective Date: xx/xx/xx |
Sample Allocation (e.g., 1x1mL, 3x5mL) |
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STAT
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Placeholder |
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Protocol Version #: XX • Effective Date: xx/xx/xx |
Sample Allocation (e.g., 1x1mL, 3x5mL) |
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STAT
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Placeholder |
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Protocol Version #: XX • Effective Date: xx/xx/xx |
Sample Allocation (e.g., 1x1mL, 3x5mL) |
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STAT
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Placeholder |
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Protocol Version #: XX • Effective Date: xx/xx/xx |
Sample Allocation (e.g., 1x1mL, 3x5mL) |
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STAT
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Placeholder |
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Protocol Version #: XX • Effective Date: xx/xx/xx |
Sample Allocation (e.g., 1x1mL, 3x5mL) |
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STAT
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FORM-00564 |
WuXi |
• Page 2 of 3 |
Revision:07 |
REQUESTED TESTING |
STAT TESTING: Some assays are eligible for STAT processing. If a requested assay
is eligible, a "STAT"
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TEST CODE |
TEST NAME |
Placeholder |
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Protocol Version #: XX • Effective Date: xx/xx/xx |
Sample Allocation (e.g., 1x1mL, 3x5mL) |
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STAT
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Placeholder |
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Protocol Version #: XX • Effective Date: xx/xx/xx |
Sample Allocation (e.g., 1x1mL, 3x5mL) |
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STAT
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Placeholder |
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Protocol Version #: XX • Effective Date: xx/xx/xx |
Sample Allocation (e.g., 1x1mL, 3x5mL) |
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STAT
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Placeholder |
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Protocol Version #: XX • Effective Date: xx/xx/xx |
Sample Allocation (e.g., 1x1mL, 3x5mL) |
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STAT
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Placeholder |
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Protocol Version #: XX • Effective Date: xx/xx/xx |
Sample Allocation (e.g., 1x1mL, 3x5mL) |
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STAT
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Placeholder |
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Protocol Version #: XX • Effective Date: xx/xx/xx |
Sample Allocation (e.g., 1x1mL, 3x5mL) |
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STAT
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Placeholder |
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Protocol Version #: XX • Effective Date: xx/xx/xx |
Sample Allocation (e.g., 1x1mL, 3x5mL) |
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STAT
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Placeholder |
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Protocol Version #: XX • Effective Date: xx/xx/xx |
Sample Allocation (e.g., 1x1mL, 3x5mL) |
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STAT
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Placeholder |
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Protocol Version #: XX • Effective Date: xx/xx/xx |
Sample Allocation (e.g., 1x1mL, 3x5mL) |
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STAT
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Placeholder |
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Protocol Version #: XX • Effective Date: xx/xx/xx |
Sample Allocation (e.g., 1x1mL, 3x5mL) |
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STAT
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Placeholder |
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Protocol Version #: XX • Effective Date: xx/xx/xx |
Sample Allocation (e.g., 1x1mL, 3x5mL) |
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STAT
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Protocol Version #: XX • Effective Date: xx/xx/xx |
Sample Allocation (e.g., 1x1mL, 3x5mL) |
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STAT
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FORM-00564 |
WuXi |
• Page X of Y |
Revision:07 |
PROVIDE THE FOLLOWING INFORMATION AS APPLICABLE |
N.A. |
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Gene Therapy or Viral Vaccine Testing
Patient Dose or Test Amount
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DNA Detection Assays
Amount of material to test
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General Safety Testing
Control
Specify: |
Sterility • Endotoxin • Bioburden Testing |
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This sample type has been submitted before. |
Yes No |
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B/F been conducted on this sample. |
Yes No |
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Sample contains antibiotics. |
Yes No |
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If requesting B/F testing, when should it be performed: |
IF ORDERING PROTOCOL #37000, THIS SECTION MUST BE COMPLETED |
N.A. |
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List cell lines:
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Perform hemagglutination? Yes No
Hemabsorption is the standard endpoint. If “yes” is selected, hemagglutination will also be performed. |
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IF CELL GROWTH IS REQUIRED FOR TESTING, THIS SECTION MUST BE COMPLETED |
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Check One: [Additional fields will then display.]
Adherent Cells Suspension Cells
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Parental Cell Line
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Temperature and % CO2 for Growth
° C = % CO2 = |
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ADHERENT CELLS SUBCULTURING INFORMATION |
Cell Dissociation Buffer
[Timeline will be adjusted accordingly.]
Specify buffer, vendor, catalog #:
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Cell Dissociation Procedure
Use default procedure
Flask will be washed with PBS once and incubated with 2mL/T150 cell dissociation reagent at 37°C until the cells are detached.
Use the following procedure (describe):
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Culture Vessels Select One
T75 and T150 tissue culture treated flasks Other – Provided by Client Describe: Other – WuXi AppTec to order [Timeline will be adjusted accordingly.]
Specify vessel, vendor, catalog #:
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SUSPENSION CELLS |
Shaker Speed
Specify rpm range: rpm |
Culture Vessels Select One Non-baffled shaker flasks Other – Provided by Client Describe: Other – WuXi AppTec to order [Timeline will be adjusted accordingly.]
Specify vessel, vendor, catalog #:
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MEDIA |
Provided by Client WuXi AppTec to provide |
Provide media component information/formulation and vendor information:
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Media type: [Timeline will be adjusted accordingly.]
Specify media, vendor, catalog #: |
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Additional Supplements N.A. FBS L-glutamine (Lonza 17-605E) Glutamax (Gibco, 35050061)
Other – WuXi AppTec to order [Timeline will be adjusted accordingly.] Specify supplement, vendor, catalog #:
Final Concentration: |
PASSAGE INFORMATION |
Range of Cell Concentration/
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Range of Seeding Concentration OR Split Ratio
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Passage
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Split Schedule Range
Perform split Day 3 or Day 4 Other – Specify:
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Feed Schedule
No feeding between splits
Other – Specify: |
Note: The passage/thaw day is considered Day 0. |
FOR CRYOPRESERVED CELLS
N.A |
Cells
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Range of Seeding Density |
Speed to centrifuge cells
Specify: |
Initial culture volume Select One
30mL in T150 flask 30mL in 125mL shaker flask Other Specify: |
Special instructions for recovering cells from cryopreservation can be provided in the “Comments” section below. |
FORM-00564 |
WuXi |
• Page X of Y |
Revision:07 |
COMMENTS & SPECIAL INSTRUCTIONS |
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N.A. |
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IMPORTANT INSTRUCTIONS REGARDING THIS FORM. READ CAREFULLY BEFORE SIGNING AUTHORIZATION BELOW. |
This sample submission
form – which must accompany each submitted
sample – acts as the official record
for what is being requested/required of WuXi AppTec regarding this
particular sample.Failure to provide this information could result in testing delays or other issues. WuXi AppTec will not be held responsible for information not provided by client. Services requested in this form will be governed in accordance with WuXi AppTec's Standard Terms and Conditions.To the extent WuXi AppTec's Standard Terms and Conditions are in conflict with an applicable agreement (Agreement) between Customer listed in this form and WuXi AppTec, such Agreement will govern. Please note for GLP studies: by signing this submission form, you authorize the personnel selected in the client information section of the form to be the primary point of contact for this study/studies. |
TESTING APPROVED BY & PROTOCOL APPROVAL |
TESTING APPROVED BY: |
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Once printed, this form must be signed before enclosing in your sample shipment or your testing will be delayed. Note: A verified / certified (only) digital / “electronic” signature is also acceptable. |
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To save an electronic copy
in your print dialog.
Always print and sign |
SIGNATURE (REQUIRED) |
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PRINT NAME |
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DATE |
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By signing above, you acknowledge that you have reviewed the most current version of the protocol(s) listed on this form and your signature constitutes approval of the protocol(s). If you would like to review any or all of the protocols, click here to email WuXi AppTec and indicate the protocols you want to review. |
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To save an electronic copy
in your print dialog.
Always print and sign |
SIGNATURE (REQUIRED) |
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PRINT NAME |
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DATE |
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SHIPPING LOCATIONS
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WuXi AppTec – Philadelphia • Attn: Central Sample Control • 400 Rouse Blvd. • Philadelphia, PA 19112 • 800.622.8820 • 215.218.5500 |
WuXi AppTec – Atlanta • Attn: Sample Staging • 1265 Kennestone Circle • Marietta, GA 30066 • 888.847.6633 • 770.514.0262 |
WuXi AppTec – St. Paul • Attn: Sample Receipt • 2540 Executive Drive • St. Paul, MN 55120 • 888.794.0077 • 651.675.2000 |
FORM-00564 |
WuXi |
• Page 3 of 3 |
Revision:07 |