FOR WUXI APPTEC USE ONLY

Sample Number and Technician Initials/Date:

 

PAYMENT METHOD (required)

A signed print copy of this form must be included in your shipment.
Be sure to complete all fields as appropriate. You will receive an
automatic warning if your form is incomplete when you try to print.
NOTE: Submitting an incomplete form will result in a testing delay.

WARNING: This form is incomplete / missing required information.
Submitting an incomplete form to WuXi AppTec will delay your testing.

If you need assistance, contact your Account Manager or Project Manager.

To print/save, always use the Print/Save button at the bottom of this form.
This will help ensure your form is not incomplete/missing required information that could delay your testing.

QUOTE NUMBER (QUO ##### - ###### - #)

 

QUO - - -

 

CLIENT INFORMATION

 

Account Number (required):

COMPANY NAME & ADDRESS         

(Address for final report shipment)

CONTACT FOR FINAL REPORT:

PHONE:

EMAIL:

SECONDARY CONTACT (if applicable/needed):

PHONE:

EMAIL:

 

If this is submission of additional material, check here:   

 

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

Sample Designation as Labeled on Vessel

General Description of Sample

Sample Designation to be Used on Report (exact wording)

Species of Origin

Biosafety Level

Has the test article been validated by WuXi AppTec? Yes No

CODE, BATCH, OR LOT NUMBER:

 

 

EXPIRATION DATE:

 

Commercial/Marketed Product? Yes No

 

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

 

 

Sample Shipment Temperature

Controlled Storage Temperature

at WuXi AppTec

 

Cells submitted for expansion
will be stored in liquid nitrogen.

NOTE: For virology testing, sample storage conditions will be determined by the Study Director.

 

Do not freeze/thaw
sample for reuse

 

May freeze/thaw
# of Times:

 

Upon test completion, samples to be:
  Discarded

Returned (Additional fee applies)

 

Provide courier company and acct. # for shipping:

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.

 

SAMPLE PREP & HANDLING INSTRUCTIONS

 

N.A.

Include pre-testing information such as dilutions, reconstitution, etc., and sample matrix or buffer components (if applicable)

 

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"
check box will appear. By checking/requesting STAT, Client understands and agrees that special fees apply.

 

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

 

 

TEST CODE

TEST NAME

 

Sample Allocation (e.g., 1x1mL, 3x5mL)

  

 

Sample Allocation (e.g., 1x1mL, 3x5mL)

  

 

Sample Allocation (e.g., 1x1mL, 3x5mL)

  

 

Sample Allocation (e.g., 1x1mL, 3x5mL)

  

 

Sample Allocation (e.g., 1x1mL, 3x5mL)

  

 

Sample Allocation (e.g., 1x1mL, 3x5mL)

  

 

Sample Allocation (e.g., 1x1mL, 3x5mL)

  

 

Sample Allocation (e.g., 1x1mL, 3x5mL)

  

 

Sample Allocation (e.g., 1x1mL, 3x5mL)

  

 

Sample Allocation (e.g., 1x1mL, 3x5mL)

  

 

Sample Allocation (e.g., 1x1mL, 3x5mL)

  

 

Sample Allocation (e.g., 1x1mL, 3x5mL)

  

 

Check here if more space is needed to list requested assays. An additional page – with space for test code listings – will be added.

 

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"
check box will appear. By checking/requesting STAT, Client understands and agrees that special fees apply.

 

TEST CODE

TEST NAME

 

Sample Allocation (e.g., 1x1mL, 3x5mL)

  

 

Sample Allocation (e.g., 1x1mL, 3x5mL)

  

 

Sample Allocation (e.g., 1x1mL, 3x5mL)

  

 

Sample Allocation (e.g., 1x1mL, 3x5mL)

  

 

Sample Allocation (e.g., 1x1mL, 3x5mL)

  

 

Sample Allocation (e.g., 1x1mL, 3x5mL)

  

 

Sample Allocation (e.g., 1x1mL, 3x5mL)

  

 

Sample Allocation (e.g., 1x1mL, 3x5mL)

  

 

Sample Allocation (e.g., 1x1mL, 3x5mL)

  

 

Sample Allocation (e.g., 1x1mL, 3x5mL)

  

 

Sample Allocation (e.g., 1x1mL, 3x5mL)

  

 

Sample Allocation (e.g., 1x1mL, 3x5mL)

  

 

 

 

FORM-00564

WuXi

• Page X of Y

Revision:07

PROVIDE THE FOLLOWING INFORMATION AS APPLICABLE

N.A.

Gene Therapy or Viral Vaccine Testing

 

Patient Dose or Test Amount

 

DNA Detection Assays

 

Amount of material to test

General Safety Testing

 

Control

 

Sterility • Endotoxin • Bioburden Testing

This sample type has been submitted before.

Yes   No

B/F been conducted on this sample.

Yes   No

Sample contains antibiotics.

Yes   No

If requesting B/F testing, when should it be performed:

 

 

IF ORDERING PROTOCOL #37000, THIS SECTION MUST BE COMPLETED

N.A.

List cell lines:

 

 

Perform hemagglutination? Yes No

 

Hemabsorption is the standard endpoint. If “yes” is selected, hemagglutination will also be performed.

 

 

IF CELL GROWTH IS REQUIRED FOR TESTING, THIS SECTION MUST BE COMPLETED

 

 

Check One: [Additional fields will then display.]

Adherent Cells Suspension Cells

 

Parental Cell Line
(e.g., CHO, HEK293, SF9)

Temperature and % CO2 for Growth

 

° C = % CO2 =

 

ADHERENT CELLS SUBCULTURING INFORMATION

Cell Dissociation Buffer

 

 

 

Cell Dissociation Procedure
Select one of these two options:

 

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):

 

 

Culture Vessels Select One

 

T75 and T150 tissue culture treated flasks

Other – Provided by Client

Other – WuXi AppTec to order

 

 

SUSPENSION CELLS
SUBCULTURING
INFORMATION

Shaker Speed
(Orbit 1.9cm)

 

Culture Vessels Select One

Non-baffled shaker flasks

Other – Provided by Client

Other – WuXi AppTec to order

 

 

 

MEDIA

Provided by Client WuXi AppTec to provide

Provide media component information/formulation and vendor information:

Media type:

 

Additional Supplements N.A. FBS L-glutamine (Lonza 17-605E) Glutamax (Gibco, 35050061)

 

Other – WuXi AppTec to order [Timeline will be adjusted accordingly.]

 

Final Concentration:

 

PASSAGE INFORMATION

Range of Cell Concentration/
Confluence
Prior to Passage

Range of Seeding Concentration

OR Split Ratio

Passage
Level / Limit

Split Schedule Range
Select One

 

Perform split Day 3 or Day 4

Other – Specify:

Feed Schedule
Select One

 

No feeding between splits

Other – Specify:

Note: The passage/thaw day is considered Day 0.

 

FOR CRYOPRESERVED CELLS

 

N.A

Cells
Per Vial

Range of Seeding Density

Speed to centrifuge cells
before plating

 

 

Initial culture volume Select One

 

30mL in T150 flask

30mL in 125mL shaker flask

Other

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

 

N.A.

 

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:

 

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.

 

 

 

 

 

 

 

 

To save an electronic copy
of this completed form, select
Adobe PDF Writer or
Microsoft XPS Document Writer

in your print dialog.

 

Always print and sign
a hard copy to ship
with your samples.

SIGNATURE

(REQUIRED)

 

PRINT NAME

 

DATE

 

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.

 

 

 

 

 

 

 

 

To save an electronic copy
of this completed form, select
Adobe PDF Writer or
Microsoft XPS Document Writer

in your print dialog.

 

Always print and sign
a hard copy to ship
with your samples.

SIGNATURE

(REQUIRED)

 

PRINT NAME

 

DATE

 

 

 
SHIPPING LOCATIONS

 
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