Purolite™ Praesto™ AP+80

Supports biosimilar development, improving process economics.

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Offering Cost-Effective Solutions to Biosimilar Development

Biosimilar medicines are revolutionizing patient care, providing an affordable alternative to traditional biologics. However, drug developers face a significant challenge in controlling production costs while achieving the high standards of efficacy and similarity required of biosimilars.

Purolite AP+80 is engineered to support large-scale purification processes necessary for the manufacturing of biosimilar medicines.

With an 80-micron bead, Purolite AP+80 offers ideal flow conditions to maximize production speed.

Purolite AP+80 offers comparable performance and improved process economics compared to market- leading resins.

Purolite™ Chromatography Resins

Purolite AP+80 is manufactured using patented Jetting technology, ensuring uniform particle size for enhanced quality and performance.

Jetting manufacturing supports sustainability through reduced use of harmful solvents and water usage. Compared to traditional methods, Jetting accelerates time to market with fewer production steps.

Features

High capacity 80 μm bead

Alkaline stable up to 0.1 M NaOH

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. Purolite 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 Purolite 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 Purolite AP+80 at 3, 4.8, 6, and 10-minute residence time.

Purolite 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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Typical Physical & Chemical Properties

Polymerstruktur

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

Partikelgröße - µm

≥ 95% within range 45 - 125 cm/h

Pressure/Flow specifications

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

pH Stabilität, Arbeitsbereich

3 - 12

pH Stabilität, CIP (kurzzeitig)

2 - 13

empfohlene Lagerung

2 - 8 °C in 20% ethanol

Purolite™ Praesto™ AP+80