Purolite Praesto™ AP+80 | Elevating Biosimilar development

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Sanità e scienze della vita

Con 40 anni di esperienza nella produzione e 30 anni di esperienza normativa, forniamo tecnologie di separazione, purificazione ed estrazione all'avanguardia per supportare le applicazioni di cromatografia e biocatalisi nel settore sanitario e delle scienze della vita.
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Società

Siamo il leader mondiale nella tecnologia di separazione, purificazione ed estrazione a base di resina, che fornisce soluzioni sostenibili per il nostro ambiente, le aziende e l'assistenza sanitaria.

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Improve Process Efficiency

Biosimilars are revolutionizing the pharmaceutical industry, offering cost-effective alternatives to biologic drugs. Process optimization is crucial for cost-efficient dual source resin production and for ensuring safety and efficacy.

Developed with an 80-micron bead, Purolite Praesto AP+80 maximizes production speed and throughput by providing ideal pressure flow conditions.

Purolite Praesto AP+80 is a comparable alternative to market-leading affinity resins and particularly suited for separations using increased bed heights to enhance process economics.

Part of the Purolite™ Affinity Resin Toolbox

Purolite Praesto AP+80 is an agarose-based affinity resin engineered to support the purification of monoclonal antibodies (mAbs) in large-scale manufacturing processes. It builds upon the innovation of Purolite’s Affinity Resin Toolbox.

The Purolite Difference

Developed in partnership with Repligen, and manufactured using Purolite’s patented Jetting technology, Purolite Praesto AP+80 offers uniform beads to ensure quality and performance.

Jetting manufacturing reduces the use of solvents and decreases wastewater to support sustainability goals. Compared to traditional methods, Jetting accelerates time to market with fewer production steps.

Features

High capacity 80 μm bead

Optimal pressure flow properties

High dynamic binding capacity up to 60 g/L

Product Data

Alkaline Stability

Sodium hydroxide (NaOH) exhibits high efficiency in removing bound proteins, nucleic acids, and lipids from bioprocess resins, alleviating the risk of fouling on heavily burdened Protein A columns. Praesto AP+80 maintains excellent capacity after exposure to 0.1 M NaOH for 400 cycles, facilitating efficient CIP and longer resin lifetime.

Pressure Flow AP-80-Pressure-Flow

With Praesto AP+80, flows of up to 350 cm/h are achievable at 25 cm bed height in a 30 cm diameter columns, within the safe operational window of less than 2 bar pressure.

Dynamic Binding Capacity

Capacity data for an IgG1 subclass monoclonal antibody on Praesto AP+80 at 3, 4.8, 6, and 10-minute residence time.

Praesto AP+80 offers comparable binding capacity to competitor resins, allowing for consistency in existing processes and use of existing columns.

Resources

Praesto AP+80 Brochure

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Praesto AP+80 IFU

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Process Scale Column Packing Instructions

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Laboratory Scale Column Packing Instructions

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Praesto® AP+80

Typical Physical & Chemical Properties

Struttura del polimero

Highly cross linked agarose

Ligand

Alkali stabilized recombinant Protein A

Dynamic binding capacity

Up to 60 mg mAb/ml resin (6 minute residence time)

Jetted Particle Size

80 µm

Distribuzione granulometrica - µm

≥ 95% within range 45 - 125 cm/h

Pressure/Flow specifications

Up to 400 cm/h (30 x 25 cm)

pH di stabilità, range operativo

3 - 12

Stabilità del pH, CIP (a breve termine)

2 - 13

Conservazione/Stoccaggio consigliato

2 - 8 °C in 20% ethanol

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