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Understanding the Options:

Plasma Fractionation - Albumin

Clarification and Prefiltration

Essential Process Requirements

• Remove colloids, aggregated and non-product proteins, lipids and particles prior to downstream purification
• Protect downstream sterilizing-grade filters, chromatography media and TFF membranes
• Must be able to withstand multiple steam-in-place or hot water sanitization cycles
• Run efficiently to ensure process economics

Recommended Filter	Filter Characteristics
Single-layer Millistak+ DE Filters (Grade 55DE) Disc Filters Capsule Filters	Better suited for large volumes >500 L High internal surface area for maximum particle capture loading Graded density matrix allows retention of particle range High porosity provides low pressure drop Although Grade 55DE is typical for this application, Millistak+ filters are available in several pore sizes and in single-layer or multi-layer configurations to accommodate the needs of each user, the degree of protection required for the downstream process and the plugging characteristics of the fluid. Choice should be based on small-scale testing.
Double-layer Millistak+ HC Filters (Grade C0HC) Disc Filters Pod Filters	Better suited for volumes <500 L or with low usage rates of less than 10 batches/year Double-layer design enhances loading capacity and filtrate quality Unique configuration allows compression of multiple process steps so prefiltration may not be required. This can lower overall filtration costs. Although Grade C0HC is ideal for this application, Millistak+ filters are available in several pore sizes and in single-layer or multi-layer configurations to accommodate the needs of each user, the degree of protection required for the downstream process and the plugging characteristics of the fluid. Choice should be based on small-scale testing.
Double-layer Milligard Filters (Grade SS, 0.5 µm + 0.2 µm Cartridge Filters Opticap Capsule Filters Optiscale Capsule Filters	Better suited for volumes <500 L or with low usage rates of less than 10 batches/year Double-layer design enhances loading capacity and filtrate quality Unique configuration allows compression of multiple process steps so prefiltration may not be required. This can lower overall filtration costs. Although Grade C0HC is ideal for this application, Millistak+ filters are available in several pore sizes and in single-layer or multi-layer configurations to accommodate the needs of each user, the degree of protection required for the downstream process and the plugging characteristics of the fluid. Choice should be based on small-scale testing.
Double-layer Polysep II Filters (Grade W3, 1.0 µm + 0.2 µm) Cartridge Filters Opticap Capsule Filters Optiscale Capsule Filters	Borosilicate glass top layer enhances particle and loading capacity Mixed esters of cellulose membrane bottom layer ensures high retention and filtrate quality Robust construction validated to withstand multiple SIP or hot water sanitization cycles Non-fiber releasing structure preserves product purity 100% integrity tested to ensure quality Available in a variety of pore sizes to accommodate the needs of each user. Grade W3 is commonly used to protect downstream 0.22 µm membrane filters. Choice should be made based on small-scale testing.

Ultrafiltration

Essential Process Requirements

• Reduce batch volumes and exchange buffer systems for efficient column operation and final formulation
• Run efficiently to ensure process economics

Recommended Filter	Filter Characteristics
Pellicon Cassettes with Biomax 10 kD Membrane	Biomax void-free membrane has exceptional caustic stability and excellent repeat performance Low feed flow requirement minimizes pumping, working and hold up volumes. Higher product recovery and flux Suspended screen in feed channel allows higher turbulence enhancing the separation process Complete range of Pellicon devices allow for easy scale-up

Sterile Filtration (liquid)

Essential Process Requirements

• Sterilizing-grade filters reduce bioburden and sterilize heat labile proteins
• Must be able to withstand multiple steam-in-place or hot water sanitization cycles
• Run efficiently to ensure process economics

Recommended Filter

Filter Characteristics

Durapore 0.22 µm Filters Cartridge Filters Optiseal Cartridge Filters Opticap Capsule Filters Optiseal Capsule Fitlers

Low protein binding sterilizing-grade PVDF membrane 100% Integrity testing and thousands of existing applications assure proven performance Although 0.22 µm is typical for this application, Durapore filters are available in several pore sizes and, in single-layer or multi-layer configurations to accommodate the degree of protection required for the downstream process and the plugging characteristics of the fluid. Choice should be based on small-scale testing. Integrity testable on-site

Product News & Releases

• Millipore Introduces Solvex™ Solvent Filters - New cartridge filters ideal for sterile manufacture of APIs
• Millipore Introduces the Mobius® MIX500 Disposable Mixing System - Increased process speed and reduced risk now in a 500L size
• Millipore Expands Its NovAseptic® Mixer Family - The new GMP30000 mixer is ideal for effective mixing in large volumes
• Millipore Introduces New Service Offer for Evaluating Mixing Solutions

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