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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 Code:
41103801
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Quality Level

material

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

agency

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

sterility

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

product line

Mobius®

packaging

package of 5 ×

parameter

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

technique(s)

buffer exchange: suitable, media fill: suitable

capacity

250 mL

impurities

<0.25 EU/mL Aqueous extraction (LAL test)

fitting

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

application(s)

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

storage temp.

10-30°C

General description

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.

Application

Croyopreserved storage of cells

Biochem/physiol Actions

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

Features and Benefits

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).

Packaging

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

Other Notes

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

Legal Information

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


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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,以生产高质量的单克隆抗体(mAbs)及其他类型的重组蛋白。工艺强化能够使他们的生产策略更具前瞻性,降低成本,并提高生产设施的灵活性。