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Merck
CN

HCDC0001L101

Mobius Gold High Cell Density Cryopreservation Assembly

(-80C), 100mL, sterile; γ-irradiated (at 25-40 kGy)

别名:

Mobius®Gold High Cell Density Cryopreservation Assembly (-80C), 100 mL

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UNSPSC Code:
41103801
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产品名称

Mobius Gold High Cell Density Cryopreservation Assembly, (-80C), 100mL, sterile; γ-irradiated (at 25-40 kGy)

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)
60 mL process volume

technique(s)

buffer exchange: suitable
media fill: suitable

capacity

100 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

Quality Level

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

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.

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

Packaging

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

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

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

How the Cellicon® filter and controller enables seamless adoption of a perfused N-1 seed train step into the cell expansion process.

This article explains how to streamline transfer of an allogeneic cell therapies process to a CDMO partner and long-term manufacturing success.

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