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Your Position: Home > Kits > - > GMP-MSCCM41

CelThera™ GMP MSC Expansion Kit (Phenol Red-free)

Transfer Cap for Square Media Bottle (PCA-25021401) is available for convenient sterile transfer of media from the bottle to closed culture systems like cell culture bags via aseptic welding.

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Cat. No.ComponentsSize
GMP-CM4101CelThera™ GMP MSC Expansion Medium (Phenol Red-free)1000 mL
GMP-CM41S1CelThera™ GMP MSC Expansion Medium Supplement3 mL

Note: 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 MSC Expansion Medium (Phenol Red-free) and mix thoroughly.

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    - PRODUCT SHOW

  • Product Details
    CelThera™ GMP MSC Expansion Medium (Phenol Red-free) is a serum-free, animal origin-free (AOF), and no antibiotics culture medium for human MSCs (hUC-MSCs, hBM-MSCs, hAT-MSCs) maintenance and expansion. It is produced under GMP conditions. It requires only 5% human platelet lysate (PLT) addition during culture. The cultured cells exhibit characteristic MSC surface marker expression and retain robust expansion rate, viability rate and trilineage differentiation capacities.

    Compared to traditional or xeno-free medium, this AOF formulation reduces potential pathogenic microorganism risks, improves batch consistency, and avoids undefined serum component interference with MSC behavior.

  • Features
    1. Serum-free, AOF, antibiotic-free.
    2. Enables high expansion, viability, and phenotype stability for MSCs.
    3. Maintains trilineage differentiation.
    4. Produced according to current GMP guidelines.
    5. No coating agent required.
  • Storage

    CelThera™ GMP MSC Expansion Medium (Phenol Red-free) is stable for 12 months when stored under 2-8°C, protect from light.
    CelThera™ GMP MSC Expansion Medium Supplement is stable for 12 months when stored under -20°C or below, protect from light.

Application Data
 - APPLICATION DATA

Different sources of MSCs P4 (hUC-MSCs, hBM-MSCs, hAT-MSCs) were cultured and passaged to P7. The cell expansion results demonstrated that CelThera™ GMP MSC Expansion Medium (Phenol Red-free) (Cat. No. GMP-MSCCM41) (add 5% PLT) exhibited excellent performance in supporting cell growth and proliferation.

 - APPLICATION DATA

Different sources of MSCs P4 (hUC-MSCs, hBM-MSCs, hAT-MSCs) were cultured and passaged to P7. Cell viability results showed that CelThera™ GMP MSC Expansion Medium (Phenol Red-free) (Cat. No. GMP-MSCCM41) (add 5% PLT) maintained excellent cell viability.

 - APPLICATION DATA

hUC-MSCs Expanded in AcroBio Medium Display Multi-Lineage Differentiation Potential.

hUC-MSC expanded in CelThera™ GMP MSC Expansion Medium (Phenol Red-free) (Cat. No. GMP-MSCCM41) differentiated into (A) osteoblasts (Alizarin Red S staining; P7), (B) adipocytes (Oil Red O staining; P7), (C) chondrocytes (Alcian Blue staining; P7).

 - APPLICATION DATA

hUC-derived MSCs were cultured and expanded in CelThera™ GMP MSC Expansion Medium (Phenol Red-free) (Cat. No. GMP-MSCCM41). At P7 MSCs were stained for mesenchymal markers .MSCs expressed CD73, CD90, CD105 >95%,HLA-DR, CD45, CD34<5%.

 - APPLICATION DATA

hBM-derived MSCs were cultured and expanded in CelThera™ GMP MSC Expansion Medium (Phenol Red-free) (Cat. No. GMP-MSCCM41). At P7 MSCs were stained for mesenchymal markers .MSCs expressed CD73, CD90, CD105 >95%,HLA-DR, CD45, CD34<5%.

 - APPLICATION DATA

hAT-derived MSCs were cultured and expanded in CelThera™ GMP MSC Expansion Medium (Phenol Red-free) (Cat. No. GMP-MSCCM41). At P7 MSCs were stained for mesenchymal markers .MSCs expressed CD73, CD90, CD105 >95%,HLA-DR, CD45, CD34<5%.

  • 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

    3. Osmolality

    4. Endotoxin Level

    5. Functionality

    6. Mycoplasma testing

    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.

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