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HCDC0001L101

Millipore

Mobius Gold High Cell Density Cryopreservation Assembly

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

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

material

device (thermoplastic elastomer)
polyethylene device
polypropylene device
silicone device

Quality Level

Agency

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

sterility

sterile; γ-irradiated (at 25-40 kGy)

product line

Mobius®

parameter

-80-60 °C temp. range (-112-140 °F)
0.3 bar max. pressure (4.4 psi)
60 mL process volume

capacity

100 mL

impurities

<0.25 EU/mL Aqueous extraction (LAL test)

application(s)

mAb

storage temp.

2-30°C

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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.

Specificity

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

Application

Croyopreserved storage of cells

Packaging

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

Components

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

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.

Legal Information

MOBIUS is a registered trademark of Merck KGaA, Darmstadt, Germany

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Regulatory Information

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Articles

This page describes the design attributes of the Cellicon® filter assembly for cell retention and how they simplify scale-up of intensified upstream processes.

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.

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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.

Our team of scientists has experience in all areas of research including Life Science, Material Science, Chemical Synthesis, Chromatography, Analytical and many others.

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