CelThera™ GMP TIL Cell Expansion Kit (Phenol Red-free)

Note: 1. A complimentary bottle of CelThera™ GMP Phenol Red Solution (0.5%) (Cat# GMP-PI1100) is supplied with this kit. For cell culture procedures requiring phenol red indicator, add 1.5 mL of this solution to 1 L of CelThera™ GMP Immune Cell Expansion Medium (Phenol Red-free) and mix thoroughly.

产品描述（Product Details）

CelThera™ GMP TIL Cell Expansion Kit (Phenol Red-free) is a serum-free culture medium specifically developed to support human TIL cell culture. It is a serum-free, animal origin-free TIL cell maintenance and expansion medium.

优势特色（Features）

1. Serum-free, animal origin-free (AOF), and exogenous growth factors free.
2. Designed to support high-fold expansion of TIL cells.
3. Suitable for large-scale TIL cell expansion.
4. Contains only recombinant proteins as components, no antibiotics added during manufacturing.

存储（Storage）

CelThera™ GMP Immune Cell Expansion Medium (Phenol Red-free) is stable for 18 months when stored under 2-8°C, protect from light.
CelThera™ GMP lmmune Cell Supplement E is stable for 24 months when stored under -20°C or below, protect from light.

质量管理控制体系（QMS）

1. 质量管理体系（ISO, GMP）
2. 质量优势
3. 质控流程

MANUFACTURING SPECIFICATIONS

ACROBiosystems GMP grade mediums are produced under a quality management system and in compliance with relevant guidelines: Ph. Eur General Chapter 5.2.12 Raw materials of biological origin for the production of cell-based and gene therapy medicinal products; USP <1043> Ancillary Materials for Cell, Gene, and Tissue-Engineered Products; ISO 20399: 2022(E), Biotechnology ? Ancillary materials present during the production of cellular therapeutic products and gene therapy products.

ACROBiosystems Quality Management System Contents：

1. Designed and Manufactured under ISO 9001:2015 and ISO 13485:2016.
2. Animal-Free materials
3. Materials purchased from the approved suppliers by QA
4. ISO 5 clean room for filling
5. Qualified personnel
6. Quality-related documents review and approve by QA
7. Fully batch production and control records
8. Equipment maintenance and calibration
9. Validation of analytical procedures
10. Stability studies conducted
11. Comprehensive regulatory support files

Request For Regulatory Support Files (RSF)  

ACROBiosystems provide rigorous quality control tests (fully validated equipment, processes and test methods) on our GMP grade products to ensure that they meet stringent standards in terms of purity, safety, activity and inter-batch stability, and each bulk QC lot mainly contains the following specific information:

1. pH
2. Sterility (USP<71>; EP<2.6.1>)
3. Osmolality
4. Endotoxin (USP<86>; EP<2.6.32>)
5. Functionality
6. Mycoplasma (USP<63>; EP<2.6.7>)
7. Batch-to-batch consistency

DISCLAIMER

ACROBiosystems GMP grade products are designed for research, manufacturing use or ex vivo use. CAUTION: Not intended for direct human use.

TERMS AND CONDITIONS

All products are warranted to meet ACROBiosystems Inc.’s (“ACRO”) published specifications when used under normal laboratory conditions.

ACRO DOES NOT MAKE ANY OTHER WARRANTY OR REPRESENTATION WHATSOEVER, WHETHER EXPRESS OR IMPLIED, WITH RESPECT TO ITS PRODUCTS. IN PARTICULAR, ACRO DOES NOT MAKE ANY WARRANTY OF SUITABILITY, NONINFRINGEMENT, MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE.

NOT WITH STANDING ANY OTHER PROVISIONS OF THESE TERMS AND/OR ANY OTHER AGREEMENT BETWEEN ACRO AND PURCHASER FOR THE PURCHASE OF THE PRODUCTS, ACRO’S TOTAL LIABILITY TO PURCHASER ARISING FROM OR IN RELATION TO THESE TERMS, AN AGREEMENT BETWEEN THE PARTIES OR THE PRODUCTS, WHETHER ARISING IN CONTRACT, TORT OR OTHERWISE SHALL BE LIMITED TO THE TOTAL AMOUNT PAID BY PURCHASER TO ACRO FOR THE RELEVANT PRODUCTS. IN NO EVENT WILL ACRO BE LIABLE FOR THE COST OF PROCUREMENT OF SUBSTITUTE GOODS.

END USER TERMS OF USE OF PRODUCT

The following terms are offered to you upon your acceptance of these End User Terms of Use of Product. By using this product, you indicate your acknowledgment and agreement to these End User Terms of Use of Product. If you do not agree to be bound by and comply with all of the provisions of these End User Terms of Use of Product, you should contact your supplier of the product and make arrangements to return the product.

The End User is aware that ACROBiosystems Inc. and its affiliate (“ACRO”) sell GMP grade products designed for research, manufacturing use or ex vivo use and not intended for human in vivo applications. The End User further agrees, as a condition of the sales of ACRO’s GMP grade products that: a) the End User will not use this GMP grade product in any procedure wherein the product may be directly or indirectly administered to humans, unless the End User has obtained, or prior to their use will have obtained, an Investigational New Drug (IND) exemption from the FDA and will use the product only in accordance with the protocols of such IND and of the Institutional Review Board overseeing the proposed research, or b) the End User will use the products outside of the United States in accordance with the protocols of research approved by the applicable review board or authorized ethics committee and regulatory agencies to which the End User is subject to in their territory.