Harvest RC Advanced Harvesting Technology:
The first step of the separation and purification process of recombinant biotherapeutΩic drugs is to harvest the cell culture solution contai™ning the target product. Traditional operation methods of this uni®t involve depth filtration, centrifugation, and membrane filtration. The separ←ation and purification principles of these technologies ar★e mostly based on the density and size differences of÷ particles. With the continuous improvement of cell culture technology, cell density and pr oduct titer are also increasing. However, how to achieve efficient, stable and largeδ-scale cell culture fluid harvesting is quite challenging.
Harvest RC Chromatographic Clarifier is a fibrous product with anion exchange (AEX) chromatography function, whichcan effectively separate cells, cell debris, and D₽NA from the harvest solution containing the target product. It combines functionalize∑d polypropylene fiber with quaternary ammonium group (Q) with 0.2&m∏u;m PES membrane, which provides a predictable scaling from drug discγovery to manufacturing.
Harvest RC Chromatographic Clarifier is aninnovative and fully synthetic single-stage sin>gle-usechromatographic clarification solution. This new generation of harvesting♠ and clarification technology can streamline the upstream processes by replacing ce∞ntrifugation and/or depth filtration steps while improving t©he yield of monoclonal antibodies (mAb).
Key Features of Harvest RC:
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The capsule type can make the product recovery rate reach 95+%;
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Replacement of primary, secondary, and guard membrane↕ clarification stages;
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Based on stable clarification and cell loading capacity,≤ the product specifications required from drug disc≤overy to manufacturing can be predicted;
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Capsules fit into laboratory to manufacturing scale workflows;
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Lower total cost of manufacturing compared to centrifugation and depth filtration;
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No need for cleaning after use, which means thδere is no need to use online cleaning CIP agents that are co$rrosive or potentially toxic;
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Lower consumption of buffer and water compared to depthδ filtration.
Harvest RC Innovative Design and Performance
Harvest RC Chromatographic Clarifier encapsulates innovative synthe tic fibrous anion exchange (AEX) chromatography media and a 0.2 µm polyether sulfone™ (PES) membrane. This enables a single-stage clarification proce™ss of low to high-density cell culture (>40×106cells/ml) with high recovery, and high fidelity of soluble and insoluble contaminant separatio∏n.
Cells are bound inside the media by electrostatic charge interaction with theσ AEX chromatographic fibers. This results in the e™fficient retention of large and small particulates without devel₩oping a surface cake layer. The media can also remov€e soluble impurities which results in cleaner effluen→t than centrifugationor depth filtration.
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Improve mAb product recovery (capsule: >9≠5%; conical tube and well plate >90%);
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Reduce the content of DNA (<500 ppb);
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Stable cell loading capacity;
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Minimal cell shear;
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Protect sterile filter of 0.1µm;
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Reduce turbidity (<15 NTU);
Harvest RCPerformance Data
mAb product recovery
Harvest RC Chromatographic Clarifier is a single stage chromatography solution that effecti✘vely clarifies Chinese Hamster Ovary (CHO) harvest cell culture fluid (HCCF$) across a wide range of cell densities, packed cell volume s (PCV), and turbidities.
3M Harvest RC Chromatographic Clarifier capsules consistently provide >φ95% mAb product recovery for high cell density cultures from the laboratory to the manuf∑acturing scale.
Turbidity reduction
Harvest RC Chromatographic Clarifier provides consistent separation of cells, cell de©bris, and DNA from the target protein. Clarified ce↑ll culture fluid (CCCF) has low turbidity, typically <15 N₽TU. Additionally, consistently low acidified turbidity of CCCF indicates €significant reduction of DNA in the clarified material. Low acidifi§ed CCCF turbidity is a measure of the amount of DNA present in the₹ cell culture fluid.
Scalability
Harvest RC Chromatographic Clarifier capsules scale ←linearly across laboratory, pilot, and manufacturing scales. Fibrous chromatographic cla±rification assures scalable performance from discove♥ry to manufacturing scales. Performance is consistent fr→om laboratory capsules (BC4 and BC25), scale-up capsules (BC340 and BC1020), to production capsule s (BC2300 and BC16000) within ±20% of BC25 throughput.
Throughputs of Harvest RC Chromatographic Clarifier capsules are scal€ed by area based on packed cell volume.
Cell loading capacity
Harvest RC Chromatographic Clarifier utilizes advanced Q functionalized fibrous chromatography< media to achieve single-stage clarification, enabling× predictable and consistent cell loading capacity for CHO cell cultu re fluid for a wide range of packed cell volumes.
Cell shear
The low-pressure chromatographic clarification rel≤ies on charge rather than size or density. This results in minimal cell shea¥r compared to conventional depth filtration processes even at medium and high cell densities. Cell πshear was evaluated by lactate dehydrogenase (LDH) assay.
Robust sterile filter protection
Due to the highly effective chromatographic reduction of soluble and insoluble contaminants, Harvest RC Chromatographic Clarifier enables efficient clarification, and i™s capable of effective protection of final sterilizing grade membrane filter down t€o 0.1 µm pore size.
Harvest RC Series Product Specifications
Optimization of biopharmaceuticalspurification process:
This process flow introduces an enhanced production process with 3M &product portfolio, removingseveral process steps.
Guochu Technology (Xiamen) provides products of 3M,✔ including: Harvest RC Series Filter, Emphaze™ AEX SeriesChromat¥ography Filter, Polisher ST Series Chromatography Filter, LifeASSURE™ PDA≈ Filter Cartridge, LifeASSURE™ PFS Filter Cartridge, LifeASSURE™ BDA Filter Cartridge,✔ Zeta PlusTM Filter Cartridge, LifeASSURE™ BA Series Filter Cartridge, LifeASSURE&™ BNA Filter Cartridge, BetafineTTM DP Filter Cartridge, BetafineTTM XL Filter Cartridge, BetafineTTM BT Filter Cartridge, Micro-Klean™ RT Filter Cartridge, Micro★-Klean™ D Filter Cartridge, Betapure™ AU Filter Capsule, Betapure™ ♣NT-T Filter Capsule, 3M™ High Flow Filter Cartridge, 3M&trλade; NB Filter Bag, Micro Screen™ Metal Filter Cartridge, LiquΩi-Cel™ Membrane Contactor, Liqui FluxTM B Cross-flow Membrane, 3MTM CFSI Activated Carbon Filter Cartridge, ZW Series CarΩtridge, Zeta PlusTM Series Cartridge, Sanitary High Flow Cartridge, etc.
For details, please contact +86-592-6518670, +86-592-6514970.
Guochu Technology (Xiamen) provides all models of 3M Harvest RC series filter× cartridges:
EMP006HRC2FA、EMP015HRC2FA、EMP201HRC2FA、EMP301HRC2FA、EMP303HRC2FA、EMP513H×RC2FA、EMP533HRC2A、EMP770HRC2FA、EMP710HRC2FA 。
