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HCDC0001L102

Mobius Gold High Cell Density Cryopreservation Assembly

(-80C), 250 mL, sterile; γ-irradiated (at 25-40 kGy)

别名:

Mobius® Gold High Cell Density Cryopreservation Assembly (-80C), 250 mL

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UNSPSC Code:
41103801
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Quality Level

400

material

C-Flex® tubing (374), device (thermoplastic elastomer), polyethylene device, polypropylene device, silicone device, 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

-80-60 °C temp. range (-112-140 °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.

2-30°C

General description

Device configuration: 5 bags per assembly
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.
Our Mobius® High Cell Density Cryopreservation (HCDC) Assembly (-80°C) is a single-use assembly specially designed to facilitate the freeze and thaw of cryopreserved cells at -80°C. Available in two assembly bag sizes of 100 mL and 250 mL, our Mobius® HCDC Assembly (-80°C) 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
All component materials, in contact with sampling liquid, meet the criteria for Class VI testing based on USP <88> Biological Reactivity, in vivo.

Packaging

Five (5) assembies per package with each assembly containing five (5) 100 mL cryo bags
Five (5) assembies per package with each assembly containing five (5) 250 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.
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
Polyethylene bags: Pureflex FilmTubing: Silicone and Thermoplastic ElastomerFittings: PolypropyleneNovaSeal Pinch Pipes: Nickel plated brassPinch 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

Impact of DMSO And Freezing Technique in Developing a High Cell Density Cryopreservation Process for Upstream Bioprocessing

Understand how considerations such as DMSO concentrations and freezing techniques are key in the successful implementation of high cell density cryopreservation (HCDC).

Seed Train Intensification Using High Cell Density Cryopreservation

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

Reducing the Need for Animal Testing for Biological Reactivity in Polymer Characterization

This page provides an overview of USP <87>, <88>, and <1031>, compares bioreactivity testing, and describes the transition of our organization towards in vitro test methods.

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