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Merck
CN

HCDC0001L0250

Mobius Gold High Cell Density Cryopreservation Assembly

(-196C), 250 mL, sterile; y-irradiated (at 25-40 kGy)

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UNSPSC代码:
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物料

(flouropolymer)
(thermoplastic elastomer)
C-Flex® tubing (374)
device
polypropylene
silicone (thermoplastic elastomer)
tubing (Pharma 65)

质量水平

Agency

according to ISO 11137
meets EN 2.6.14
meets JP 4.01
meets USP 85

无菌性

sterile; γ-irradiated (level of 25-40 kGy)

产品线

Mobius®

包装

package of 5 ×

参数

-196- 60 °C temp. range (-321- 140 °F)
0.3 bar max. pressure (4.4 psi)
150 mL process volume

技术

buffer exchange: suitable
media fill: suitable

容量

250 mL

杂质

<0.25 EU/mL Aqueous extraction (LAL test)

配件

plug (plug-end 1/8"HB)
port (end-ported 2x 1/8"HB)

应用

cell therapy
gene therapy
life science and biopharma
liquid processing
mAb
ophthalmics
parenterals
pharma/biopharma processes
viral therapy
waste management

储存温度

2-30°C

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一般描述

Device configuration: 5 bags per assembly
Our Mobius® High Cell Density Cryopreservation (HCDC) Assembly (-196C) is a single-use assembly specially designed to facilitate the freeze and thaw of cryopreserved cells in liquid nitrogen vapor phase (? -196°C). Available in two assembly bag sizes of 100 mL and 250 mL, our Mobius® HCDC Assembly (-196C) enables seed train inoculation with cells at a higher cell density and larger volume compared to the traditional seed train process using vials, which significantly accelerates the cell expansion process. Our Mobius® single-use assembly also provides a closed processing environment preventing contamination while improving process reproducibility.

应用

Croyopreserved storage of cells

生化/生理作用

All component materials, in contact with sampling liquid, meet the criteria for Class VI testing based on USP <88> Biological Reactivity, in vivo.
Application

特点和优势

Standard products eliminate design and manufacturing lead times.

Designed to facilitate the freeze and thaw of cryopreserved cells in liquid nitrogen vapor phase ( -196°C).

包装

Five (5) assembies per package with each assembly containing five (5) 100 mL cryo bags

其他说明

Bags manufactured under ISO Clean Room Class 8 conditions in a facility certified to ISO 14644-1 standards. Assembly performed under ISO Clean Room Class 7 conditions in a facility certified to ISO 14644-1 standards.
Fluoropolymer bags: Tubing: Silicone and Thermoplastic ElastomerFittings: PolypropyleneNovaSeal Pinch Pipes: Nickel plated brass
Pinch clamp: Nylon

法律信息

C-Flex is a registered trademark of Saint-Gobain Performance Plastics Corp.
MOBIUS is a registered trademark of Merck KGaA, Darmstadt, Germany

法规信息

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商品

High cell density cryopreservation (HCDC) is a closed processing alternative to the traditional seed train expansion process. Learn more about the benefits of HCDC.

相关内容

Biopharmaceutical developers need efficient, productive upstream processes that deliver high quality monoclonal antibodies (mAbs) and other types of recombinant proteins. Process intensification can future-proof their manufacturing strategies, reduce costs, and increase facility flexibility.

生物制药开发商需要高效、高产的上游工艺来提供优质的单克隆抗体(mAb)和其他类型重组蛋白。工艺强化可确保生产策略适应未来发展需求、降低成本并提升设施灵活性。

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