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Merck

HCDC0001L0100

Millipore

Mobius Gold High Cell Density Cryopreservation Assembly

(-196C), 100 mL, sterile; y-irradiated (at 25-40 kGy)

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About This Item

UNSPSC Code:
41103801

material

(flouropolymer)
(thermoplastic elastomer)
device
polypropylene
silicone (thermoplastic elastomer)

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)

parameter

-196- 60 °C temp. range (-321- 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
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.

Specificity

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

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.

Legal Information

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

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Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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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.

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.

Cellvento 4CHO-X Expansion Medium enhances cell biomass for bioreactor inoculation in cell expansion stages.

Related Content

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.

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.

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