CelThera™ GMP T Cell Expansion Medium (Phenol Red-free)

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Product Details

CelThera™ GMP T Cell Expansion Medium (Phenol Red-free) in bag format is compatible with closed-system processing for clinical production processes. The 5L volume medium support scaling of cell therapy manufacturing workflows. The bag format utilizes medical grade multilayer film with four weldable options and allows for easier integration with standard cell therapy equipment.

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

Compared to traditional culture media or xeno-free culture media, animal origin-free culture media can better reduce the risk of introducing potential pathogenic microorganisms during culture process, improve batch-to-batch consistency, and prevent T cell overactivation by undefined components in the serum.

CelThera™ GMP T Cell Expansion Medium (Phenol Red-free) does not require the addition of any serum or serum replacements and also maintains the high fold expansion of T cells. If users choose to add serum or serum replacement, the dosage should be determined by specific T cell applications.

Features

1. Closed system process.
2. Weldable TPE and PVC tubing with 4 options.
3. Minimized manual touchpoints.
4. Ready-to-Use Format.
5. Animal-free and USP Class VI materials.
6. Serum-free, animal origin-free (AOF), and exogenous growth factors free.
7. Designed to support low-density seeding and high fold expansion of T cells.
8. Suitable for large-scale T cell expansion.
9. No additional serum or serum replacements needed.
10. T cell phenotypes similar to media supplemented with serum or serum replacement.
11. Contains only recombinant proteins as components, no antibiotics added during manufacturing.
12. Designed under ISO 9001:2015 and ISO 13485:2016.
13. Manufactured and QC tested under a GMP compliance factory.

Storage

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

Shipping

Components may ship in separate packages with different temperature controls (dry ice or blue ice). Please inquire about the shipping cost. Inspect all parcels upon arrival.

ACRO Quality Management System

1. QMS(ISO, GMP)
2. Quality Advantages
3. Quality Control Process

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. GMP-certified facility (compliance with FDA cGMP, EMA GMP, ICH, ISO9001/13485/MDSAP, and certified by third-party SGS, UL, and RX360)
2. Animal origin-free materials, equipments, and facilities
3. Materials sourced only from approved suppliers
4. ISO 5 cleanrooms and automatic filling equipment
5. Professional quality personnel and training programs
6. Validated analytical testing methods in accordance with the ICH guidelines
7. Safety Testing (Sterility, Mycoplasma, etc): compliant with USP, EP, etc
8. In-depth stability studies
9. Fully batch production and control records
10. Equipment maintenance and calibration

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

ACROBIOSYSTEMS - LEGAL NOTICES FOR GMP GRADE PRODUCTS

1. PRODUCT USE RESTRICTIONS & PROHIBITIONS

• 1.1 ACROBiosystems ("ACRO") GMP grade products ("Products") are designed for research, manufacturing use or ex vivo use.
• 1.2 Products are NOT intended for diagnostic purposes or for direct or indirect administration into humans.
• 1.3 Purchaser shall not market, distribute, or resell Products obtained from ACRO without ACRO's prior written consent.

2. REVERSE ENGINEERING PROHIBITED & CONFIDENTIALITY

• 2.1 Purchaser shall not reverse-engineer, decompile, disassemble, sequence, analyze via bioinformatics, or otherwise attempt to discover the structure, sequence, composition, construction, manufacturing process, or any trade secret embodied in the Products. Purchaser shall not permit any third party to undertake such activities.
• 2.2 All specifications, data, and know-how related to the Products provided by ACRO are ACRO's confidential information and shall be protected accordingly.

3. LIMITED WARRANTY & DISCLAIMERS

• 3.1 ACRO warrants solely that Products will conform to their published specifications when used under normal, specified laboratory/manufacturing conditions and within their labeled expiration date. THIS IS THE ONLY WARRANTY PROVIDED.
• 3.2 Purchaser assumes ALL risk and responsibility for:
  (a) Determining the suitability of Products for Purchaser's intended application(s).
  (b) Obtaining any necessary regulatory approvals or intellectual property licenses for Purchaser's use.
  (c) Compliance with all applicable laws, regulations (including but not limited to cGMP/GLP where claimed), and industry standards.
  (d) Conducting all necessary quality control, safety, efficacy, and validation testing of Products within Purchaser's process or final product.
  (e) Proper storage, handling, and use of Products according to ACRO's instructions.
  
• 3.3 ACRO EXPRESSLY DISCLAIMS ALL OTHER WARRANTIES, WHETHER EXPRESS, IMPLIED, STATUTORY, OR OTHERWISE, INCLUDING BUT NOT LIMITED TO: (A) WARRANTIES OF MERCHANTABILITY; (B) WARRANTIES OF FITNESS FOR A PARTICULAR PURPOSE; (C) WARRANTIES OF NON-INFRINGEMENT; AND (D) WARRANTIES ARISING FROM COURSE OF DEALING OR USAGE OF TRADE.

4. LIMITATION OF LIABILITY

• IN NO EVENT SHALL ACRO, ITS AFFILIATES, OR SUPPLIERS BE LIABLE FOR ANY OF THE FOLLOWING, HOWSOEVER ARISING (WHETHER IN CONTRACT, TORT (INCLUDING NEGLIGENCE), STRICT LIABILITY, STATUTE, OR OTHERWISE):
  (a) LOST PROFITS, LOST REVENUE, LOST SAVINGS, LOSS OF USE, LOSS OF DATA, BUSINESS INTERRUPTION, OR ANY OTHER INDIRECT, INCIDENTAL, SPECIAL, PUNITIVE, OR CONSEQUENTIAL DAMAGES.
  (b) ANY DIRECT DAMAGES, COSTS, OR EXPENSES EXCEEDING THE AMOUNT PAID BY PURCHASER FOR THE SPECIFIC PRODUCT(S) GIVING RISE TO THE CLAIM.
  (c) DAMAGES ARISING FROM: (i) MISUSE, ABUSE, OR UNAUTHORIZED MODIFICATION OF PRODUCTS; (ii) USE BEYOND THE EXPIRATION DATE; (iii) IMPROPER STORAGE OR HANDLING; (iv) ACCIDENTAL DAMAGE; (v) FAILURE TO CONDUCT ADEQUATE VALIDATION OR TESTING BY PURCHASER; (vi) INFRINGEMENT CLAIMS RELATED TO PURCHASER'S USE; OR (vii) THE COST OF PROCURING SUBSTITUTE GOODS OR SERVICES.
  (d) ANY PERSONAL INJURY, DEATH, OR DAMAGE TO TANGIBLE PROPERTY TO THE EXTENT PERMITTED BY LAW.

5. END USER ACKNOWLEDGEMENT & COMPLIANCE

• 5.1 By accepting, opening, or using the Products, the End User (Purchaser or its downstream recipient) agrees to be irrevocably bound by all terms herein.
• 5.2 End User explicitly acknowledges the Products are NOT FOR HUMAN ADMINISTRATION and agrees not to use them in any in vivo human application, directly or indirectly.
• 5.3 End Users unwilling to accept these terms must immediately: (a) cease all use; (b) notify ACRO or their supplier; and (c) return the unopened, unused Products.
• 5.4 ACRO reserves the right to audit End User's compliance with these restrictions upon reasonable notice.

ACRO has the right, at its sole discretion, to modify, add or remove any terms herein without notice to Purchaser and/or End User. Any changes to these terms are effective immediately following the updating of such changes on ACRO’s website or published specifications or product-related documents.