| 应用领域 | 医疗卫生,生物产业 |
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大规模细胞扩增培养系统
20亿级大规模细胞扩增培养系统
-从科研到GMP级临床无缝链接
Scinus 3D大规模细胞扩增培养系统用于符合GMP要求的贴壁细胞3D大规模细胞扩增培养。该系统尤其适合临床治疗级别的前期细胞扩增培养，如：MSC、胚胎干细胞（ES)、成纤维细胞（Fibroblast）、软骨细胞（Chondrocyte)、胰腺导管细胞（Pancreatic duct cell).
Scinus 3D大规模细胞扩增培养系统采用APPLIKON技术，可以自动、控制温度、溶解氧浓度、pH值。
系统包含温度、溶解氧浓度、pH值及生物量传感器。一次性反应袋体积可以通过生物量传感器自动调整体积，同时自动补充所需微载体。温度传感器可以控制温度，酸氧传感器则控制溶解氧浓度、pH值。
采用微载体3D细胞培养，节约人力及耗材用量，培养基用量多可以节省80%。
参数：
培养体系：150 mL to 1 L
细胞量：～1 x 109
温度范围：25 – 40°C
pH值: 6.0-8.0 ，+/- 0.03
溶解氧浓度：0 – 100%，+/-5%
微载体表面积：>4m2/L
一次性的细胞扩增反应袋，微载体扩增细胞，电脑控制检测调节溶解氧，pH值及生物量。比传统的2D培养更安全，一次性培养的细胞更多，培养袋的体积可按需灵活调整（从150mL-1L不等），使用范围广，适用于各种贴壁细胞，如间骨髓间充质干细胞(msc)，胚胎干细胞、成纤维细胞、软骨细胞或胰管细胞。
该系统利用磁性微球载体和磁悬浮技术，使贴有细胞的微球载体悬浮在培养液中，确保了高质量、高密度的细胞繁殖，突破了传统有盖培养皿、培养瓶或微孔板细胞培养耗时繁琐，细胞产量微小等局限性。
Publications | |
| Preparing for cell culture scale-out: establishing parity of bioreactor- and flask-expanded mesenchymal stromal cell cultures | Abstract Background:Cell-based therapies have the potential to become treatment options for many diseases, but efficient scale-out of these therapies has proven to be a major hurdle. Bioreactors can be used to overcome this hurdle, but changing the culture method can introduce unwanted changes to the cell product. Therefore, it is important to establish parity between products generated using traditional methods versus those generated using a bioreactor. Methods:Mesenchymal stromal cells (MSCs) are cultured in parallel using either traditional culture flasks, spinner vessels or a new bioreactor system. To investigate parity between the cells obtained from different methods, har-vested cells are compared in terms of yield, phenotype and functionality. Results:Bioreactor-based expansion yielded high cell numbers (222–510 million cells). Highest cell expansion was observed upon culture in flasks [average 5.0 population doublings (PDL)], followed by bioreactor (4.0 PDL) and spin-ner flasks (3.3 PDL). Flow cytometry confirmed MSC identity (CD73+, CD90+ and CD105+) and lack of contaminating hematopoietic cell populations. Cultured MSCs did not display genetic aberrations and no difference in differentiation and immunomodulatory capacity was observed between culture conditions. The response to IFNγ stimulation was similar for cells obtained from all culture conditions, as was the capacity to inhibit T cell proliferation.Conclusions:The new bioreactor technology can be used to culture large amounts of cells with characteristics equivalent to those cultured using traditional, flask based, methods.Keywords:Bioreactor, Mesenchymal stromal cells, Cell therapy (Open PDF) |
White Papers | |
| Efficient expansion of mesenchymal stem cells in a closed bioreactor system. ISCT 2017 | Cell therapies typically require hundreds of millions of cells for one application. For mesenchymal stem cells (MSCs), a typical dose is based on 2 million cells/kg body weight. These cells are obtained from donors, but initial cell numbers are extremely low. Therefore, these cell numbers need to be increased dramatically before they can be administered to the patient. Standard flask-based cell culture is extremely inefficient for cell therapy production. (Open PDF) |
Posters | |
| Optimization of Microcarrier-based Culture of Muscle Precursor Cells ISCT 2018 | Stress urinary incontinence (SUI) affects over 200 million people worldwide. A novel approach to treat SUI is to locally administer autologous muscle precursor cells (MPCs) into the defective sphincter muscle. For the treatment of one patient millions of cells are required. Therefore the production of these MPCs needs to be scaled up. Scinus Cell Expansion BV developed a novel bioreactor technology using a microcarrier based expansion process which provides a safe and (cost-) effective procedure for the clinical upscale of MPCs. Here, we present the optimization of a microcarrier based culture of MPCs, using a downscaled model of the SCINUS technology. (Open PDF) |
| A single-step expansion system for large-fold expansion of bone marrow-derived MSCs ISCT 2018 | Cell therapies require (cost-)effective production to ensure that novel therapies are commercially viable. Closed, automated bioreactors can improve handling and safety while also reducing costs by limiting operator involvement, clean room requirements and expenditure of consumables. However, current closed solutions do not support the expansion to hundreds of millions cells from the limited initial cell numbers found in a biopsy without multiple reseeding steps. We developed novel bioreactor technology (Figure 1) with which high cell numbers can be grown from a bone marrow biopsy in a single expansion system, eliminating the need for labourand cost-intensive expansion protocols. (Open PDF) |
| Single-step expansion of adipose-derived stem cells with platelet lysate in SCINUS Cell expansion system ISCT 2018 | Adipose-derived stem cells (ASCs) can be isolated from fat tissue obtained after e.g. abdominoplasty. Advantages of fat tissue over bone marrow as a source for stem cells include easier accessibility and availability of larger volumes. Costeffective production of cellular therapies requires efficient culture platforms that address major cost drivers: labor costs, clean room requirements and consumable expenditure. At the same time, process automation can increase quality and reliability of the cell product. Here we present the culture of over 500 million ASCs starting directly from a stromal vascular fraction in medium supplemented with human platelet lysate (hPL) using our SCINUS Cell Expansion system (figure 1). Human PL was used as an alternative to FBS as it contains no animal derived products and it is a rich source for varying growth factors. (Open PDF) |
| Large-scale expansion of MSCs using one-step, closed-system bioreactor technology. ISCT 2017 | Cost-effective production of cellular therapies requires efficient culture platforms that address major cost drivers: labour costs, clean room requirements and consumable expenditure. At the same time, process automation can increase quality and reliability of the cell product. Therapies using mesenchymal stem cells (MSCs) represent a major part of cell-based clinical trials. Consequently, this cell type serves as an excellent source to demonstrate (cost-) effective culture using bioreactor technology. We demonstrate efficient large-scale culture of MSCs, using the Scinus Cell Expansion system. (Open PDF) |
| Culture of Adipose-derived Stem Cells on Microcarriers using the Scinus Cell Expansion bioreactor. ISCT 2017 | Adipose-derived stem cells (ASCs) can be isolated from fat tissue obtained after abdominoplasty. Advantages of fat tissue over bone marrow as a source for stem cells include the easier accessibility, and availability of larger volumes. For the production of stem cells for cell therapy in patients, an upgrade to clinical large scale culture (> 200x106 cells) is necessary. Clinical scale cultures require a reproducible and efficient process. For this, a microcarriers based culture is a very suitable method. Within the Scinus Cell Expansion system (see Figure 1) adherent cells can be cultured on microcarriers in a closed environment under GMP conditions. A process for culturing large quantities of ASCs using microcarriers (MCs) using the Scinus Cell Expansion system was developed. (Open PDF) |
| Cost-effecient, closed system MSC culture to therapeutically relevant quantities. ISCT 2016 | Achieving cost-efficient production of cell therapies is a major challenge, with medium costs and operator handling being significant contributors. Medium usage can be greatly reduced by using microcarrier-based expansion to reach high cell numbers in minimal volume. Microcarriers (MC) also enable closed, singlestep procedures in bioreactors that limit operator involvement and clean room requirements. Scinus Cell Expansion System is a bioreactor designed for the culture of adherent cells in a closed, single-use bag. (Open PDF) |
| One-step bone marrow-derived msc culture using novel bioreactor technology. ISCT 2016 | Culture of bone marrow-derived MSCs for clinical application is a costly process, in large part due to the requirement for cleanroom facilities necessitated by numerous open procedures. The use of closed bioreactor systems can reduce costs and improve quality of the final cell product. However, these systems are usually ill suited to culture cells to large quantities directly from an aspirate. Here we present a closed system to culture millions of MSCs starting from a small volume bone marrow aspirate, while retaining MSC properties. (Open PDF) |
| Culture of adipose-derived stem cells on microcarriers. ISCT 2016 | Adipose-derived stem cells (ASCs) can be isolated from fatty tissue. Similar to MSCs isolated from bone marrow, ASCs have multi-lineage potential and can be used as a potential source in regenerative medicine. Additionally, fat tissue is more accessible than bone marrow, and larger volumes can be obtained. For the production of cells for cell therapy in patients, an upgrade to clinical large scale culture (> 200x106 cells) is necessary. Clinical scale cultures require a reproducible and efficient process. Therefore, a process for culturing of large quantities of ASCs using microcarriers (MCs) was developed. (Open PDF) |
Co Publications | |
| Dissolvable Microcarriers for hMSC and hiPSC Production and Recovery ISSCR 2017 | A new dissolvable microcarrier technology was developed that supports efficient cell production and recovery while eliminating the need for microcarrier cell separation. Dissolvable microcarriers are made from calcium cross-linked polygalacturonic acid polymers that are easily dissolved using a solution of EDTA and pectinase. To facilitate cell adhesion in serum-containing and serum-free applications, microcarriers are pre-coated with either porcine-derived denatured Collagen or Corning® Synthemax® II, a synthetic vitronectin peptide polymer. We demonstrate human mesenchymal stem cell (hMSC) and human induced pluripotent stem cell (hiPSC) growth on dissolvable microcarriers in spinner flasks and bioreactors. Upon microcarrier dissolution, nearly 100% of cells were recovered, and cells maintained their respective phenotype and differentiation capability. Open PDF |
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