Standard Operating Procedure

Title: Immune Cell Serum Replacement (ICSR) Thawing Page 1 of 2

1. Purpose
1.1. This procedure provides instructions on how to thaw Immune Cell Serum Replacement
(ICSR) and its associated documentation.
2. Scope
2.1. This procedure applies to Immune Cell Serum Replacement (ICSR) thawing prior to IL-2
Growth Media Production at TCF-04.
This is an electronically controlled document. User is responsible for verifying and using the effective version.

3. References
3.1. MBR-00075: IL-2 Growth Media, 1L
3.2. FRM-13147: ICSR Thawing Form
3.3. FRM-08980: Equipment Use Logbook
3.4. FRM-08982: Refrigerator Use Logbook

e
3.5. SOP-00704: Wiping of Materials and Equipment Prior to Entering and Leaving Grade D,
tiv
Grade C, and Grade B.

4. Definitions
4.1. ICSR: Immune Cell Serum Replacement.
fec
5. Responsibilities
5.1. Manufacturing Lead/Supervisor:
5.1.1 Communicates the quantity of ICSR(s) to thaw for each of IL-2 Growth Media
Production to manufacturing personnel.
Ef

5.2. Manufacturing Personnel:

5.2.1 Performs ICSR Thaw per this SOP.
5.2.2 Documents all thawing activities using corresponding logbooks during thawing
process.
5.2.3 Prints and completes FRM-13147.
6. Safety
6.1. Always use PPE (personal protective equipment) when handling contents and touching
interior surfaces.
7. Equipment and Supplies
7.1. -20°C Thermo Fisher Revco Freezer.
7.2. Panasonic 2-8°C Refrigerator.
8. Procedure
8.1. Thawing ICSR:
8.1.1. When instructed to thaw ICSR(s), manufacturing personnel prints FRM-13147 in
D-Staging using clean room paper.

Doc. Status Effective Document No. SOP-11355

Effective Date 28 Oct 2019 GVault Ver. No. 1.0
Date Printed 16 Dec 2019 Legacy Doc. No.
 Standard Operating Procedure

Title: Immune Cell Serum Replacement (ICSR) Thawing Page 2 of 2

8.1.2. Manufacturing personnel retrieves ICSR(s) required for each IL-2 Growth Media
production from -20°C freezer and completes step 1.1 on FRM-13147.
8.1.3. Manufacturing personnel transfers the frozen ICSR(s) to the 2-8°C refrigerator
to thaw overnight to dissolve into a solution and completes step 1.2-1.3.
8.1.3.1 Manufacturing personnel temporarily archives FRM-13147 in a plastic
sleeve overnight.
8.1.4. Manufacturing personnel removes ICSR(s) from the 2-8°C refrigerator prior to
This is an electronically controlled document. User is responsible for verifying and using the effective version.

IL-2 Growth media production and completes step 1.4 on FRM-13147.

8.1.4.1 Manufacturing personnel transfers ICSR(s) along with completed section
1.0 on FRM-13147 to the media manufacturing suite per SOP-00704.
8.1.5. Manufacturing personnel attaches FRM-13147 to MBR-00075 for review, after

e
completion of step 2.0.

9. Attachments
9.1. N/A
tiv
10. Revision History Summary
fec
Originator Version Summary of Changes Rationale for Changes

C. Rosso 1 New document, initial release N/A

Ef

Doc. Status Effective Document No. SOP-11355

Effective Date 28 Oct 2019 GVault Ver. No. 1.0
Date Printed 16 Dec 2019 Legacy Doc. No.
 Document No.: SOP-11355 Document Version: 1 .0
Name: SOP-11355 Immune Cell Serum Replacement (ICSR) Thawing
Document Type: Governance and Procedures
Document Subtype: Procedure
This is an electronically controlled document. User is responsible for verifying and using the effective version.

Classification:
Title: Immune Cell Serum Replacement (ICSR) Thawing

e
Approved By | Verdict Capacity | Date Approved

Peter Fastenau, Sr Manager, Manufacturing

tiv Functional Approval
Approve 24-Oct-2019 07:42:32 GMT+0000
fec
Ruiz Astigarraga, Sr Process Engineer I Functional Approval
Approve 24-Oct-2019 11:49:41 GMT+0000

Adi Spruijt, Sr QA Specialist QA/Compliance Approval

Ef

Approve 24-Oct-2019 12:16:48 GMT+0000

Doc. Status Effective Document No. SOP-11355

Effective Date 28 Oct 2019 GVault Ver. No. 1.0
Date Printed 16 Dec 2019 Legacy Doc. No.