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- Cat. No.ComponentsSizeGMP-CM4101CelThera™ GMP MSC Expansion Medium (Phenol Red-free)1000 mLGMP-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.
产品展示（Product Show）
产品描述（Product Details）
CelThera™ GMP MSC Expansion Kit (Phenol Red-free) is a chemically defined, animal origin-free (AOF) culture medium for human MSCs maintenance and expansion, and no antibiotics are added during manufacturing. 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, chemically defined medium formulation reduces potential pathogenic microorganism risks, improves batch consistency, and avoids undefined serum component interference with MSC.
优势特色（Features）
- Chemically defined, AOF, superior biological safety.
- Enables high expansion, viability, and phenotype stability for MSCs.
- Maintains trilineage differentiation.
- Produced according to current GMP guidelines.
- No coating agent required.
存储（Storage）
CelThera™ GMP MSC Expansion Medium (Phenol Red-free) is stable for 24 months when stored under 2-8°C, protect from light.
CelThera™ GMP MSC Expansion Medium Supplement is stable for 24 months when stored under -20°C or below, protect from light.质量管理控制体系（QMS）
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数据展示
应用数据（Application Data）
Isolation and continuous passage of primary UC-MSCs.
The Wharton's jelly tissue blocks cut into 1-3 mm³ were plated in 150mm Petri dishes at a density of 1 piece/cm². The Cell counting results showed that the number of cells with the ACRO CelThera™ GMP MSC Expansion Kit reached 2.73E+06 on day 12. Passages P1 to P7 were all cultured in 6-well plates at a seeding density of 7000/cm² and a culture duration of 3 days. On average, each generation was amplified by 17 times. The amplification factor of the P3 generation was approximately 5,000 times, and the cell viability remained above 95%.
Isolation and continuous passage of primary AT-MSCs.
Adipose tissue was digested and processed to obtain P0 cells, which were subsequently seeded in 6-well plates. Following 9 days of culture with ACRO CelThera™ GMP MSC Expansion Kit, the cell yield per well reached 1.17E+06. Passages P1 to P7 were all cultured in 6-well plates with a seeding density of 7000/cm² and a culture duration of 3 days, and the cell yield per well of each passage reached the million level, and the cell viability remained above 95%.
Morphological observations were conducted on ACRO group cells from Passage 1 (P1) to Passage 7 (P7). Results showed that cell morphology remained stable from the outgrowth of primary tissue-derived cells to high-passage P7 expansion with no significant abnormal changes across P1-P7.
Morphological observations were conducted on ACRO group cells from Passage 1 (P1) to Passage 7 (P7). Results showed that cell morphology remained stable from the outgrowth of primary tissue-derived cells to high-passage P7 expansion with no significant abnormal changes across P1-P7.
Different sources of MSCs P4 (hUC-MSCs, hBM-MSCs, hAT-MSCs) were cultured and passaged to P7. The cell expansion results demonstrated that the medium from AcroBio (with 5%hPL) exhibited excellent performance in supporting cell growth and proliferation.
Different sources of MSCs P4 (hUC-MSCs, hBM-MSCs, hAT-MSCs) were cultured and passaged to P7. Cell viability results showed that AcroBio's medium (with 5%hPL) maintained excellent cell viability.
hUC-MSCs Expanded in AcroBio's MSC Kit Display Multi-Lineage Differentiation Potential. hUC-MSC expanded in CelThera™ GMP MSC Expansion Kit (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).
This verification conducted the detection of mesenchymal cell markers on P1 and P7 MSCs, the positive rates of MSC-specific markers CD73, CD90, and CD105 were > 95%, while the positive rates of hematopoietic cell and other irrelevant cell markers CD34, CD45, HLA-DR, CD14, and CD19 were < 2%. These results met the identification standards for mesenchymal stem cells proposed by the International Society for Cellular Therapy (ISCT), indicating that the MSC phenotype was stable and of high purity, and possessed typical characteristics of mesenchymal stem cells.
This verification conducted the detection of mesenchymal cell markers on P1 and P7 MSCs, the positive rates of MSC-specific markers CD73, CD90, and CD105 were > 95%, while the positive rates of hematopoietic cell and other irrelevant cell markers CD34, CD45, HLA-DR, CD14, and CD19 were < 2%. These results met the identification standards for mesenchymal stem cells proposed by the International Society for Cellular Therapy (ISCT), indicating that the MSC phenotype was stable and of high purity, and possessed typical characteristics of mesenchymal stem cells.
大规模培养数据（Large-scale Culture Verification）
1.25×10⁷ cells were inoculated into the bioreactor with the culture medium supplemented to a final volume of 250 mL. Subculturing was performed every 5 days for a total of three times; after 14 days of cultivation, the cell expansion fold reached 1000, the total cell count rose to 1.2×10¹⁰ with cell counting conducted at each passage, and the cell viability remained above 95%.
ACRO CelThera™ GMP MSC Expansion Medium can effectively support the 3D culture of mesenchymal stem cells, and maintains a very high cell attachment rate during the passage process. During the expansion and culture process, the proportion of cell aggregation remained at an ideal level throughout the entire passage stage, and the aggregation proportion in all passage stages was lower than 20%.
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重要声明
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：
- GMP-certified facility (compliance with FDA cGMP, EMA GMP, ICH, ISO9001/13485/MDSAP, and certified by third-party SGS, UL, and RX360)
- Animal origin-free materials, equipments, and facilities
- Materials sourced only from approved suppliers
- ISO 5 cleanrooms and automatic filling equipment
- Professional quality personnel and training programs
- Validated analytical testing methods in accordance with the ICH guidelines
- Safety Testing (Sterility, Mycoplasma, etc): compliant with USP, EP, etc
- In-depth stability studies
- Fully batch production and control records
- 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:
- pH
- Sterility (USP<71>; EP<2.6.1>)
- Osmolality
- Endotoxin (USP<86>; EP<2.6.32>)
- Functionality
- Mycoplasma (USP<63>; EP<2.6.7>)
- Batch-to-batch consistency
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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.
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(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.
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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.
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