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Monoclonal Antibody(mAb)

Monoclonal Antibody(mAb)

Monoclonal Antibody(mAb)

01
Cell Line Development


Process Requirements

Product of InterestProduct Features → Process Benefits
During cell line revival, expansion, and seed bank establishment, low-flow, low-shear feeding and sampling transfer are essential to avoid damaging early-stage sensitive cells while ensuring batch-to-batch consistency.

Xpanflow® Peristaltic Pump

Xdspure®Tubing Modules

Exospure® EPT Abrasion-Resistant Tubing

·Low speed, precise constant flow — the Xpanflow® peristaltic pump maintains high flow rates and precise constant flow at low speeds → Meets the need for slow, uniform feeding during cell culture

·Paired with Xdspure® Tubing Modules and Exospure® EPT Abrasion-Resistant Tubing→ Long-duration feeding without frequent pump tube replacement — less downtime and lower contamination risk






02
Culture Media & Buffers


Process Requirements

Product of InterestProduct Features → Process Benefits

Culture media and buffers must be precisely formulated according to recipes and delivered to bioreactors/chromatography systems at stable flow rates. Flow fluctuations during formulation and transfer directly affect the uniformity of nutrient supply and downstream process consistency.

 XAccurflow®high-precision diaphragm pump

Exospure®  Tubings & Components

 ArcXpure® Tubings

Exodc®Fluid Components



· High-precision stable output — the XAccurflow® series delivers stable output across the full speed range, maintaining consistent flow even at extremely low speeds of 1–10 rpm→ Uniform formulation and refilling flow with excellent batch-to-batch consistency

· Pairs with high-precision diaphragm pumps for fluid flow accuracy of ±0.5%–1% → Accurate recipe proportions, avoiding process fluctuations from over- or under-dosing

· Low shear and ultra-low pulsation → Protects sensitive components in media and the activity of downstream fluids

· Wide flow range: 0.9 LPH–1000 LPH

· Pre-assembled single-use tubing assemblies (Exospure®EPS tubing, ArcXpure® manifolds, etc.) with quick connections → Lower cross-contamination risk and shorter assembly time






03
Fermentation

Process Requirements

Product of InterestProduct Features → Process Benefits

During cell culture, precise feeding transfer and micro-volume reagent addition (e.g., glucose, inducers, antifoaming agents) are required. Deviations in feed flow rate directly affect cell density, metabolic state, and target product expression levels.

Xpanflow® Peristaltic Pump

Xdspure® Tubing Modules

Exospure® EPT Abrasion-Resistant Tubing

Exodc®Xmate Needle Sampling Valve

·Low speed, precise constant flow — the Xpanflow® peristaltic pump maintains high flow rates and precise constant flow at low speeds → Meets the need for slow, uniform feeding during cell culture

·Paired with Xdspure® Tubing Modules and Exospure® EPT Abrasion-Resistant Tubing→ Long-duration feeding without frequent pump tube replacement — less downtime and lower contamination risk






04
Virus Harvest / Clarification


Process Requirements

Product of InterestProduct Features → Process Benefits
After fermentation, the harvested fluid contains cells, cell debris, host cell proteins, and the target antibody. Efficient solid-liquid separation during the clarification stage must protect the activity of the target product; the clarified fluid then proceeds to downstream purification.

Xcrossflow® Hollow-Fiber Membrane Modules

XAccurflow®High-Precision Diaphragm Pump

Exospure® Tubing & Components

ArcXpure® Tubing Manifolds

Exodc® Fluid Components

Xezconnector®Quick Connectors


· Xcrossflow® open hollow-fiber channels with asymmetric membrane fiber cross-sections → High flux, high retention, low shear, and fouling resistance — for stable, repeatable filtration

·XAccurflow® high-precision diaphragm pump — low-shear transfer and filtration → Reduces target antibody aggregation and activity loss

Pressure capability up to 6 bar→Meets clarification filtration requirements with improved filtration efficiency

· Single-use tubing and Xezconnector® quick connectors for rapid line setup → Shorter batch changeover time and lower cross-contamination risk





05
Chromatography


Process Requirements

Product of InterestProduct Features → Process Benefits

Protein A affinity chromatography and polishing chromatography (cation/anion exchange, hydrophobic interaction) are core steps in monoclonal antibody purification. Loading volume and gradient elution precision directly determine resolution, purity, and yield; chromatography systems demand high flow accuracy, low pulsation, and pressure capability from pumps

XAccurflow® High-Precision Diaphragm Pump

Exospure®EPS  Transfer Tubing

Exodc® Fluid Components

Xezconnector® Quick Connectors


·High flow accuracy, comparable to mass flow meters (±0.5%–1%)→ Accurate loading volume and controllable gradient elution concentration — improved purity and yield of the target product;

 Supports extremely low speeds down to 1 rpm with pump speed linearity R² > 0.99 → Maintains linear output during long, low-flow-rate elution — stable elution peak shape;

Low-shear four-diaphragm alternating motion for ultra-low pulsation output → Reduces pulsation disturbance to the column bed, extending chromatography resin lifetime;

Pressure capability up to 6 bar→Meets chromatography process requirements with improved chromatography efficiency

· Single-use tubing and Xezconnector® quick connectors for rapid line setup → Shorter batch changeover time and lower cross-contamination risk







06
TFF

Process Requirements

Product of Interest

Product Features → Process Benefits

During concentration and buffer exchange (UF/DF), high-fold concentration and thorough buffer exchange must be achieved while controlling transmembrane pressure (TMP) and flow rate. Pump flow stability, low shear, and system controllability directly affect yield, membrane lifetime, and process scalability.


XAccurflow® High-Precision Diaphragm Pump

Exods®Manual Cassette Ultrafiltration System

(Lab)

Exods®Manual Hollow-Fiber Ultrafiltration System

(Lab)

Exods® Fully Automatic Intelligent Ultrafiltration System

(Pilot / Production)

Exods®Fully Automatic Ultrafiltration System(GMP)

 Exospure® Tubing & Components

Exodc® Fluid Components

Xezconnector®Quick Connectors


· XAccurflow® high-precision diaphragm pump — high flow accuracy, comparable to mass flow meters (±0.5%–1%)→Precise, stable tangential flow rate — reduces the risk of concentration polarization;

Low shear, continuous stable transfer→Prevents flow decay at elevated pressures, protecting cassettes and fluid activity

Proportional linear output across the full backpressure range, with stable flow output at 6 bar → Stable TMP control — consistent membrane flux and excellent batch-to-batch consistency

· Exods® manual & automatic ultrafiltration systems — integrated manifold, forged diaphragm valves, and dead-leg-free tubing design→ Controllable bioburden with verifiable CIP effectiveness

Automatic systems support coordinated multi-parameter control of TMP/flow rate/pressure→ Eliminates manual operation errors — automatic concentration, constant-volume/batch automatic buffer exchange, and automatic product collection

Meets scale-up needs across R&D, pilot, and full-scale production

· Single-use tubing and Xezconnector® quick connectors for rapid line setup →Shorter batch changeover time and lower cross-contamination risk







07
Sterile Filtration


Process Requirements

Product of Interest

Product Features → Process Benefits

0.2 μm sterile filtration provides a microbial barrier for drug substance/intermediates. Filter feed must be delivered at a stable, low differential pressure to prevent pressure fluctuations from affecting membrane lifetime and filter integrity.


XAccurflow®High-Precision Diaphragm Pump

Exospure®Tubing & Components

Exodc®Fluid Components

Xezconnector®Quick Connectorstors



·XAccurflow® high-precision diaphragm pump — low-shear transfer and filtration

→ Reduces target antibody aggregation and activity loss

Pressure capability up to 6 bar→Meets sterile filtration process requirements with improved filtration efficiency

· Single-use tubing and Xezconnector® quick connectors for rapid line setup → Shorter batch changeover time and lower cross-contamination risk






08
Drug Substance Filling

Process Requirements

Product of Interest

Product Features → Process Benefits

Large-volume, high-value drug substance filling demands precise metering, low hold-up, and cross-contamination prevention, while meeting data integrity and batch traceability requirements. Filling losses directly impact product economics.


Exoduc®Fully Automatic Intelligent Dispensing System

Exospure® Tubing & Components

Exodc® Fluid Components

Xezconnector® Quick Connectors


· Exoduc® Fully Automatic Intelligent Filling System — independent precise control per filling station, load cell accuracy ≥ C3, with instant automatic shut-off upon reaching the target weight→ Accurate fill weight with excellent batch-to-batch consistency

 Automatic collection of head/tail fractions and automatic recovery of residual fluid from the lines after filling →Maximized yield with reduced loss of high-value drug substance

 Contact-free instrumentation and valves throughout the lines, with actuators physically isolated from the fluid path→ Eliminates cross-contamination risk by design

Siemens PLC + industrial PC, SQL database, and automatic recovery after power failure→ Complete, traceable data with ensured compliance

· Single-use tubing and Xezconnector® quick connectors for rapid line setup → Shorter batch changeover time and lower cross-contamination risk






09
Formulation & Filling


Process Requirements

Product of Interes

Product Features → Process Benefits

Drug product filling requires precise metering, aseptic transfer, and durable, wear-resistant pump tubing, avoiding the introduction of particles, microorganisms, and metal ions during filling—while meeting the demands of high batch yield and rapid changeover.


Xpanflow® Peristaltic Pump

Xdspure®Tubing Modules、

Exospure® EPT Abrasion-Resistant Tubing

Exospure® EPS Transfer Tubing


·

Xpanflow® peristaltic pump maintains high flow rates and precise constant flow at low speeds→ Accurate filling metering with stable fill rates, adaptable to different fill volumes

Peristaltic pump tubing delivers contact-based transfer → with no metal parts contacting the fluid

Xdspure® tubing Modules (continuous operation >1,000 h) fit quickly and precisely into the pump head → Less downtime for tube changes — higher throughput

Exospure® EPT wear-resistant tubing (TPV, wear-resistant, low particle shedding)→ Minimal particle generation during long-term operation — safeguards drug product cleanliness

Exospure® EPS transfer tubing → Stable pressurized transfer of the sterile-filtered drug solution to the filling point — lower leakage risk











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