Document Title:
Cell Banking Information
Eurofins Document Reference:
1-P-QM-FOR-9009289
Revision: 4
Historical Reference: Form 7371
Effective date: Sep 3, 2015
Status: Effective
CELL BANK INFORMATION
Sponsor Company and Contact Name:
Cell Line Identification:
Cell Origin / Species:
NEWLY PREPARED CELL BANK
Intended use of prepared cells:
Banks(s) Required (Check All that Apply)
R&D
GMP – Non Production
GMP – Production
Research Cell Bank (R & D)
Master Cell Bank (MCB)
Working Cell Bank (WCB)
Desired Deliverable Number of Vials:
Cell Bank Acceptance Criteria (if any):
By default, we use Nunc 1.8-mL external threaded Cryotubes (www.ThermoScientific.com, Catalog #375418). If another size or type is desired, the type
of vial may have to be evaluated for Ingress of Hydrogen Peroxide at an additional cost prior to performing Sterility Testing.
Vials for Bank(s):
Desired Volume per Vial:
Default
1
Other (Include Vendor and Catalog #):
Desired Cell Concentration:
mL
x10^
cells/mL
By default, the vials will be labeled with white 33x13mm labels. Information printed on the label includes by default:

Cell Line Identification including type of bank (e.g., MCB, WCB, etc.)
Labeling:

Passage Number
● Lot Number
● Vial Number

Date vialed (at least month and year)
Enter any other information
you would like on the
labels:
PRE-BANK TESTING
Mycoplasma and Sterility testing are required to be performed on the submitted source vials. Eurofins Lancaster Laboratories will also test media and
critical reagents for Mycoplasma and Sterility. At the client’s discretion, pre-bank testing of media and reagents may be omitted, relying instead on the
manufacturer’s Certificates of Analysis. ELLI reserves right to reject certificates upon review of the testing previously performed.
Have Mycoplasma and Sterility testing
been performed on the source vials prior
to submission?
No
(The number of required vials will be determined based on required tests)
Yes
(Please provide Certificates of Analysis and submit at least 2 vials for banking)
Perform pre-bank reagent testing?
Yes
No
SOURCE VIAL INFORMATION
Lot Number (if applicable):
Passage Number:
Expected Cell Viability (%):
Expected Total Conc. (cells/mL):
Approximate Volume per Vial (mL):
Freeze Medium:
(if ELLI will perform Pre-Bank testing)
Same as below
Different
(please describe)
COMPLETE GROWTH MEDIUM
Please list the medium base as the first component. Be sure to list every component, including serum and other supplements (if applicable). Only those
components listed will be added to the final complete medium formulation.
Component Name
Vendor
Catalog #
Conc. in Medium
Formulation
1.
Balance
2.
%
3.
%
4.
%
5.
%
Hold Time from Preparation Date:
(e.g., 1 month, 6 weeks, 30 days etc.)
Special Preparation Instructions:
(if applicable)
Page 1 of 5
Will be Supplied by
Client (Y/N)?
Document Title:
Cell Banking Information
Eurofins Document Reference:
1-P-QM-FOR-9009289
Revision: 4
Historical Reference: Form 7371
Effective date: Sep 3, 2015
Status: Effective
FREEZING MEDIUM
If the freezing medium consists of complete growth medium plus other components (e.g., cryoprotectant), please list “Complete Growth Medium” or
“CGM” as the first component. Be sure to list every component. Only those components listed will be added to the final freezing medium formulation.
Component Name
Vendor
Conc. in Medium
Formulation
Catalog #
1.
Will be Supplied by
Client (Y/N)?
Balance
2.
3.
Hold Time from Preparation Date:
(e.g., use same day, 1 month, 6 weeks, 30 days etc.)
Special Preparation Instructions:
(if applicable)
CELL GROWTH PROCEDURE
Cell Adherence Type:
Incubation Conditions:
Shaking Conditions:
Adherent
37±1oC; 5±1%CO2
Stationary
Suspension
Other
Shaking RPM:
Biphasic
Cell Thaw
Please describe the way you thaw your cell line.
If unknown or if you have no preference, mark
Use Eurofins Lancaster Laboratories’ cell thawing method
Subpassage
Describe your subpass procedure and subpass criteria in detail.
For Adherent cultures, indicate confluence of a monolayer at subpass (e.g. 90-100%) and seeding density per flask (e.g. 1.5x106 cells
per 225cm2 flask). Alternatively, seeding density can be expressed in cells per cm2. If expressed in cells/mL, please provide how many
mLs/flask is required for all flasks used.
For Suspension cultures, indicate seeding density (e.g. seed at 2-4x105 cells/mL) and subpass density (e.g. split cells when they
reach 1x106 cells/mL)
Cell bank Harvest
Describe any specifics with regards to the cell bank harvest procedure (if there are any).
Page 2 of 5
Document Title:
Cell Banking Information
Eurofins Document Reference:
1-P-QM-FOR-9009289
Effective date: Sep 3, 2015
Revision: 4
Historical Reference: Form 7371
Status: Effective
POST-BANK CHARACTERIZATION TESTING
The amount of post-bank testing is dependent on the intended use of the prepared bank (e.g., Production or Non-Production) and the amount of
characterization required for your processes. The most common post-bank tests are listed below. Please indicate the post-bank testing you require.
Test
Special Requests
Comments
1.
Mycoplasma
Unless otherwise requested, testing for Mycoplasma according to the
USP/EP/PTC methods will be applied for Production Banks and Rapid
mycoplasma test will be applied for Non-Production Banks.
2.
Sterility
Unless otherwise requested, testing for Sterility will be applied to all banks.
3.
4.
5.
6.
7.
8.
9.
10.
PROJECT TIMING
Desired Delivery:
(required for Cell Bank Preparation projects only)
Analysis Stasis/Interference Timing (check one):
Complete any Stasis/Interference testing prior to initiating the associated analysis (safest approach, but delays release).
Perform any Stasis/Interference testing concurrently with the associated analysis (less delay, but slightly elevated risk).
Post-Bank Testing Timing (check one):
Complete Mycoplasma and Sterility testing prior to initiating other post-bank tests (safest approach, but delays release).
Perform all post-bank testing concurrently (less delay, but slightly elevated risk).
Multiple Bank Preparation Timing (if applicable, check one):
Begin WCB preparation only after MCB is QA-released (safest approach, but significantly delays WCB release).
Begin WCB preparation only after MCB Mycoplasma and Sterility are complete (safe approach, but delays WCB release).
Prepare WCB concurrently with MCB post-bank testing (least WCB delay, but slightly elevated risk).
ADDITIONAL COMMENTS
PROJECT TIMING
Page 3 of 5
Document Title:
Cell Banking Information
Eurofins Document Reference:
1-P-QM-FOR-9009289
Effective date: Sep 3, 2015
Revision: 4
Historical Reference: Form 7371
Status: Effective
FORM INFORMATION AND INSTRUCTIONS
This form is for information gathering in order to provide an accurate quote and to provide a platform for discussion around the preparation of your
cell bank(s). Please be as complete as possible, since this information will not only be used for quoting purposes but also as a starting point for the
creation of the Batch Records for the bank(s). Missing or incorrect information will lead to an inaccurate quote or to delays in initiation and preparation of
the bank. Generally, fields requiring input are not shaded and may be filled in by typing. Where a check box is present for a desired option, double-click
on the
, and choose “Checked” to produce a
. Please feel free to contact your ELLI Client Service Representative for aid in completing this
form or for any questions regarding ELLI’s Cell Banking Services offerings.
Cell Bank Information
Information provided in this section ensures that Lancaster Laboratories can track the project and provide appropriate guidance for preparing and
testing the cell bank(s).
 Sponsor Company & Contact Name: Your Company and your name. If you know your ELLI account number, please include that as well.
 Cell Line Identification: This designation will be used for labeling the prepared vials. It can be an internal designation for the line, but must be
precise enough to identify the specific cell line to be banked.
 Cell Origin / Species: Cell Origin could be a culture collection, Research, etc. Please include the species of origin, as that may affect how
the cells are handled or affect the testing required.
Newly Prepared Cell Bank
This section allows you to communicate your needs for ELLI’s Cell Banking Services
 Intended Use of Prepared Bank(s): This choice affects the regulations applicable to production and the post-bank release testing required.
Generally, “GMP Production” banks are those directly involved in the manufacturing process for biologics/therapies consumed by a patient.
“GMP Non-Production” banks are those that are not directly involved in the biologic/therapy manufacturing process but may be used to
release biologics/therapies consumed by a patient (e.g., for use in bioassays). Research and Development (“R&D”) banks are those that will
be used for research and development and will have no direct/indirect patient contact.
 Banks Required
o
Research Cell Bank – Check this box if you desire ELLI to prepare a bank for R&D and indicate the number of vials.
o
Master Cell Bank – Check this box if you desire ELLI to prepare for a Master Cell Bank and indicate the number of vials.
o
Working Cell Bank – Check this box if you desire ELLI to prepare for a Working Cell Bank and indicate the number of vials.
NOTE: ELLI will prepare a suitable number of additional vials for use in Post-Bank Characterization Testing.
 Desired Volume/Concentration: Standard parameters are 1 mL/vial at a concentration of 1.1x10 7 cells/mL. Choose the parameters to suit
your needs.
 Labeling: Additional information can be included upon request. We will work with you to ensure that the vial labels meet your needs.
You will have final label approval prior to preparing the cell bank(s).
 If you have any special requests regarding the cell bank (e.g., required minimum viability, animal origin free handling, etc.), please indicate the
requests under “Additional Comments”.
Pre-Bank Testing
At least Mycoplasma and Sterility testing must be performed on the source material. This step ensures that we prepare your bank(s) using
uncompromised source material and that our Cell Banking facilities are protected from microbial contamination. These tests either can have been
performed prior to submission (if acceptable Certificates of Analysis can be provided to ELLI) or can be performed at ELLI prior to initiating the bank.
Whether ELLI must perform Pre-Bank testing affects the number of vials that need to be submitted. Submitting two (2) vials for Banking is preferred to
provide a vial for culture initiation and to provide a backup vial. If Pre-Bank testing is required, the number of vials varies based on the required tests. If
you are not able to provide the ideal number of vials for culture and pre-bank testing, contact your client service representative and we will work with you
to ensure that we can perform all required testing on the vials that you are able to provide.
 One vial to start the culture for banking
 One backup vial for banking
 Bacteriostasis/Fungistasis (B/F) testing directly on vials of the source material: +7 vials
 Sterility testing directly on vials of the source material: +2 vials
 B/F and/or Sterility testing on an expansion of the source material: +1 vial (will cover all tests)
 Mycoplasmastasis and/or Mycoplasma testing on an expansion of the source material: +1 vial (will cover all tests)
Mycoplasma and Sterility testing must be performed on the media and critical reagents used to prepare the bank. At the Sponsor’s discretion, the
vendor Certificates of Analysis (CoA) may be used to determine acceptance of the media and critical reagents, however the Sponsor assumes the risk of
preparing the bank using those materials. ELLI will review the Certificates of Analysis and the procedures used to generate the results. Alternatively
ELLI can confirm the manufacturer’s testing to further ensure that the materials received are free from microbial contamination by performing
Mycoplasma and Sterility testing at our facility (at additional cost). If you desire confirmatory pre-bank testing of some or all of the reagents, indicate
below which reagents require testing.
NOTE: We reserve the right to reject testing based on the review of Certificates of Analysis (e.g., missing tests or tests performed according to
unacceptable test methods). In the event of rejected Certificates of Analysis, the appropriate pre-bank testing at ELLI will be quoted.
Page 4 of 5
Document Title:
Cell Banking Information
Eurofins Document Reference:
1-P-QM-FOR-9009289
Effective date: Sep 3, 2015
Revision: 4
Historical Reference: Form 7371
Status: Effective
Source Vial Information
Information provided in this section will fully describe the source material to help maintain traceability and will aid the Cell Banking specialists in
initiating the cell culture for banking.
 Vial information: Copy this information from the source material vials so we can reconcile the vials when we receive the source material.
 Freezing Medium: If ELLI will be performing Pre-Bank testing on the source material, indicate whether the freezing medium in the source vials
is the same as will be used to cryopreserve the prepared bank(s) or whether the freeze medium of the source vial is different from that of the
bank that will be prepared. If the matrices are different, describe the source vial freeze medium. Different matrices may affect the
number/timing of Post-Bank Characterization Tests.
Complete Growth Medium / Freezing Medium
Completely describe the growth and freeze media for the bank(s) to ensure that the prepared bank(s) meets your internal requirements. It is
important that the media are completely described, including the base medium and any sera or other supplements (e.g., L-glutamine, cryoprotectants,
etc.). If a solution of a chemical must be prepared and added to the medium, clearly indicate the preparation of that chemical solution (including
concentration and hold time) under “Special Preparation Instructions.” If any components are proprietary and/or will be Sponsor-supplied, please
indicate “Y” for that component. Otherwise, ELLI will plan on requisitioning the listed media and reagents from distributors. If pre-bank testing is
required for a given component, you can use the Comments field to indicate that.
Cell Growth Procedure
Our Cell Culture Maintenance procedures are written from a technique-based standpoint to allow for flexibility in application. This section will be
used to indicate the specific culture maintenance requirements, providing instructions on which techniques and parameters to use for your cell line.
 Cell Adherence, Incubation Conditions, Shaking Conditions: Indicate the appropriate responses
 Cell Thaw, Subpassage, Cell Harvest: Tell us any information that is important for culturing and harvesting your cells.
Post-Bank Characterization Testing
After the preparation of your cell bank(s), we will perform Post-Bank characterization testing to ensure that the bank meets expected quality
standards. At a minimum, we recommend Mycoplasma and Sterility testing. The application of these tests is described under the “Comments” column.
We also recommend performing all applicable matrix interference testing, particularly for GMP Production banks. Additional characterization
tests may be added to satisfy your internal requirements for the bank. Contact your ELLI service representative for a catalog of tests that we offer that
may be pertinent to your cell bank(s). List the names of any additional tests you require.
Project Timing
Indicate how ELLI should handle the timing of your cell banking project in order to meet your needs.
 Desired Delivery: Please tell us your desired timeframe for delivery (e.g., Quarter/Year, Month/Year, etc.)
 Analysis Stasis/Interference Timing: Generally, stasis/interference tests are performed prior to initiating the associated analysis. Most cell
banks have little risk of interfering with analyses so they are candidates for performing preparatory tests and actual analysis concurrently. If
testing is performed concurrently and the cells show interference, additional charges may apply in order to repeat the analysis after completion
of stasis/interference testing.
 Post-bank Testing Timing: Performing Mycoplasma and Sterility testing prior to initiating other post-bank tests prevents unnecessary testing in
the event that a cell bank is contaminated. ELLI’s facilities and procedures are in place to avoid contamination of a prepared bank, but if all
post-bank testing is performed concurrently and the cell bank shows microbial contamination, additional charges may apply in order to repeat
the analyses after preparation of a new cell bank.
 Multiple Bank Preparation Timing (if you are requesting multiple banks): Waiting until the MCB is tested and QA-released ensures that the
WCB is not prepared using unsuitable source material, but can delay preparation of the WCB by several months. Waiting until the MCB
passes Mycoplasma and Sterility testing ensures that the WCB is prepared using source material that is not microbiologically contaminated,
but can delay preparation of the WCB by over a month. ELLI’s facilities and procedures are in place to avoid contamination of a prepared
bank, but if the WCB is prepared concurrently with MCB post-bank testing and the MCB proves to be unsuitable, additional charges may apply
in order to prepare a new WCB.
Page 5 of 5