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3M™ Harvest RC Centrate Chromatographic Clarifier

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3M™ Harvest RC Centrate Chromatographic Clarifier

Om produkten

Designed to effectively clarify Chinese Hamster Ovary (CHO) cell culture centrates produced by conventional and single-use conical plate (e.g., disc stack) centrifuges, 3M™ Harvest RC Centrate Chromatographic Clarifier is a single-stage chromatography solution that employs a synthetic fibrous anion exchange (AEX) Q-functional chromatography media to enable product recoveries of >95% and cell shear-related impurity reduction.

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Single-stage chromatographic clarification for centrate in recombinant protein therapeutic manufacturing

Single-stage chromatographic clarification for centrate in recombinant protein therapeutic manufacturing
3M™ Harvest RC Centrate Chromatographic Clarifier encapsulates innovative synthetic fibrous AEX Q-functional chromatography media combined with an asymmetric Q-functional polyamide membrane with a 0.2 µm qualifying zone. This enables effective single-stage clarification of CHO cell culture centrates produced by conventional and single-use conical plate (e.g., disc stack) centrifuges. Electrostatic interactions with a positively charged ligand immobilised on a fibre matrix and a downstream polyamide membrane capture soluble and insoluble impurities, resulting in efficient retention of a wide range of particles that have not been effectively separated by centrifugation or are produced by cell shear during centrifugation. Specifically, the AEX mechanism enables efficient capture of impurities <0.5 µm that are difficult to capture with traditional depth filtration and membrane filtration.
Cleaner centrate for an improved downstream process
mAb product recovery

mAb product recovery

The innovative synthetic fibrous AEX chromatographic clarification media of 3M™ Harvest RC Centrate Chromatographic Clarifier effectively clarifies CHO cell culture centrates produced by conventional and single-use conical plate (e.g., disc stack) centrifuges. The single-mode electrostatic separation mechanism and high throughput media enables product recoveries of >95%.

Cell shear-related impurity reduction

Cell shear-related impurity reduction

Achieve high quality and consistent clarified centrate using 3M™ Harvest RC Centrate Chromatographic Clarifier for CHO cell culture centrate. The clarified centrate has low turbidity (<15 NTU), low DNA (<500 ppb) and the ability to protect a downstream sterile filter (>500 L/m2 for 0.1 μm filter).

Scalability

Scalability

From lab to manufacturing scale devices, 3M™ Harvest RC Centrate Chromatographic Clarifier provides a predictable and scalable solution aligned to process workflows.

The innovative synthetic fibrous AEX chromatographic clarification media enables a single-stage centrate clarification from CHO cell cultures with high product recovery and high fidelity of soluble and insoluble impurity removal. The 0.2 µm asymmetric Q-functional polyamide membrane, which is downstream of the fibrous chromatographic clarification media, distributes the flow across the AEX media bed and enables the protection of the downstream sterilising grade membrane filter. Also, the 0.2 µm functionalised polyamide membrane enables simple process endpoint measurement using pressure reading.
Clarify centrate like never before
Separation by charge

Separation by charge

Consisting of a range of high-capacity, single-use synthetic chromatographic clarification products that separate by charge, the 3M™ Harvest RC Centrate Chromatographic Clarifier was designed with a fibre chromatography media to effectively capture cell shear-related insoluble impurities in the submicron size range that are typically present in centrate feed streams.

Particle size control

Particle size control

3M™ Harvest RC Centrate Chromatographic Clarifier provides effective reduction of a wide range of particle sizes that are typically present in centrate feed streams. The fibre chromatography technology is highly effective at capturing the population of <0.5 µm particles that are difficult to remove using traditional depth filtration.

Robust sterile membrane filter protection

Robust sterile membrane filter protection

Due to the highly effective chromatographic reduction of soluble and insoluble impurities, 3M™ Harvest RC Centrate Chromatographic Clarifier enables efficient centrate clarification. This allows the effective protection of the final sterilising grade membrane filter down to 0.1 µm pore size.

Resisting clarification stage particle breakthrough

Resisting clarification stage particle breakthrough

The Q-functionalised fibrous media and membrane of the 3M™ Harvest RC Centrate Chromatographic Clarifier can prevent particle breakthrough, which can impact membrane filter performance. With wet-laid media present in depth filters, particle breakthrough can occur, creating pressure buildup across the membrane filter stage, which destabilises the clarification process.

3M™ Harvest RC Centrate Chromatographic Clarifier is part of the 3M™ Harvest RC Chromatographic Clarifier platform. Now you can rely on one consistent scalable clarification platform for all development phases and process scales. The platform includes 3M™ Harvest RC Chromatographic Clarifier, for direct clarification and 3M™ Harvest RC Centrate Chromatographic Clarifier, for centrate clarification. These innovative products provide a scalable clarification platform solution that can compress clarification process trains while providing consistent and comparable fluid quality to streamline process development and impact speed to market.

Click here to view the user manual.

  • Single-stage centrate clarification for process compression and streamlining of process development.
  • Enables de-risking of clarification process development, scale-up and tech transfer for faster speed to market.
  • Synthetic, functionalised fibrous media provides effective soluble impurity removal in centrate, including DNA and cell shear-related submicron particle reduction.
  • Predictable performance scalability for consistent centrate clarification at various process scales.
  • The single-mode electrostatic separation mechanism and high-throughput media enable product recoveries of >95%.
  • Provides comparable effluent quality to 3M™ Harvest RC Chromatographic Clarifier for a modern clarification platform.
  • Lower consumption of buffer or water compared to depth filtration.
  • Alkaline-resistant capsules for pre-use sanitisation.

Föreslagna användningsområden

  • BC170, BC340, BC1020, BC2300 and BC18400: Biopharmaceutical processing applications of aqueous-based pharmaceuticals (drugs) and vaccines in accordance with the product instructions and specifications and cGMP requirements, where applicable.
  • BC4 and BC25: Biopharmaceutical processing applications of aqueous-based pharmaceuticals (drugs) and vaccines in accordance with the product instructions and specifications and GLP requirements, where applicable.

Produktspecifikationer

Användningsområden
Användningsområden

Tagning och klargöring

Mikrometerklassning
Mikrometerklassning

0.2 μm

Filterteknik
Filterteknik

Anjonbyteskromatografi

Slutmodifiering
Slutmodifiering

3/4" Sanitary, Luer-Lok, 1-1/2" Sanitary

Total diameter (metrisk)
Total diameter (metrisk)

24.1 cm, 7.7 cm, 4.3 cm, 45.2 cm

Totalhöjd (imperial)
Totalhöjd (imperial)

4.09 in, 2.09 in, 2.32 in, 3.39 in, 2.24 in, 5.98 in, 7.99 in

Totalhöjd (metrisk)
Totalhöjd (metrisk)

10.4 cm, 5.3 cm, 5.9 cm, 8.6 cm, 5.7 cm, 15.2 cm, 20.3 cm

Kategorinamn
Kategorinamn

Kromatografifilter

Flödestakt (metrisk)
Flödestakt (metrisk)

4.2 ml/min

Flödestakt (imperial)
Flödestakt (imperial)

0.001 gal/min

Branscher
Branscher

Läkemedelstillverkning

Övergripande Diameter (Imperial)
Övergripande Diameter (Imperial)

9.49 in, 3.03 in, 1.69 in, 17.8 in

Filtertyp
Filtertyp

Engångsbruk

Nettovikt
Nettovikt

1.1 kg, 69.2 g, 14.3 g, 75.8 g, 3.4 kg, 1.6 kg, 9.8 kg

Produktserie
Produktserie

Harvest RC

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