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Understanding the Options

Protein and Antibody Downstream Processing

Column Protection

Essential Process Requirements

• Reduces bioburden levels
• Protects and extends the life of downstream chromatographic media
• Preserves product purity

Recommended Filter	Filter Characteristics
Durapore PVDF Filters (0.22 mm or Multilayer 0.45 mm + 0.22 mm) Durapore 0.22 mm Cartridge Multilayer Cartridge Durapore 0.22 mm Optiseal cartridge Durapore 0.22 mm Opticap Capsule Multilayer Opticap Capsule Optiscale Capsules	Sterilizing-grade filters assure reduction of contaminating microorganisms that shorten the life of chromatography media Low-binding PVDF membrane assures protein yeld 100% Integrity testing ensures quality Although 0.22 mm is typical for this application, Durapore 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. Can be integrity testable on-site
Millipore Express SHF 0.2 mm PES Filters Cartridge Filters Opticap Capsule Filters Optiscale Capsules	Sterilizing-grade PES membrane providing broad chemical compatibility across a wide pH range (1–14) Robust construction validated for multiple SIP cycles 100% integrity testing ensures quality Asymmetric pore structure delivers extremely high flow rates at low pressure drop Can be integrity tested on-site Available in single-layer 0.2 mm (SHF) or double-layer 0.5 mm + 0.2 mm (SHC) configurations. The degree of protection required for the downstream process and the plugging characteristics of the fluid will guide this selection. Choice should be based on small-scale testing.

Viral Clearance

Essential Process Requirements

(Optional for mammalian cell expression systems)

• Ensure product safety against viruses
• Highly validated and reliable technology
• Maximize product recovery
• Preserves product purity

Recommended Filter	Filter Characteristics
Viresolve NFP PVDF Filters	>4 log removal of parvovirus and other small viruses Robust PVDF membrane >98% recovery of protein up to 160 kD 100% Integrity testing assures performance Can be integrity tested on-site To enhance filter performance and capacity, Millipore suggests using the Viresolve Prefilter in series
Viresolve NFR PES Filters	>6 log removal of retroviruses (80–120 nm) >98% recovery of protein (IgG) 100% Integrity testing assures performance Can be integrity tested on-site

Ultrafiltration

Essential Process Requirements

• Concentration, buffer exchange and final formulation
• Maximize product recovery
• Fast, robust process able to accommodate feed fluid variations
• Wide chemical compatibility with cleaning agents
• Easily scalable from lab to manufacturing scale

Recommended Filter	Filter Characteristics
Pellicon C Screen Cassettes with Ultracel PLC Membranes	Low feed flow requirement minimizes pumping, working and hold up volumes Highly retentive regenerated cellulose membranes offer good permeate flux and withstand process upsets Robust low binding void-free membranes provide excellent repeat performance Choose a membrane molecular weight cut-off 3–5X smaller than the protein to be retained. Choice should be based on small-scale testing.

Sterile Filtration

Essential Process Requirements

• Sterilizing-grade step to reduce bioburden
• Highly validated and reliable technology
• Preserves product purity
• Ensures product safety

Recommended Filter	Filter Characteristics
Durapore 0.22 mm PVDF Filters Cartridge Filters Optiseal Cartridge Filters Opticap Capsule Filters Optiseal Capsule Fitlers	Sterilizing-grade PVDF membrane won’t bind valuable protein 100% Integrity testing and thousands of existing applications assure proven performance Although 0.22 mm is typical for this application, Durapore 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. Integrity testable on-site
Millipore Express PES Filters Cartridge Filters Opticap Capsules Optiscale Capsules	Sterilizing-grade PES membrane providing broad chemical compatibility across a wide pH range (1–14) Robust construction validated for multiple SIP cycles 100% integrity tested to ensure quality Asymmetric pore structure delivers extremely high flow rates at low pressure drop Can be integrity tested on-site Although double-layer 0.5 mm + 0.2 mm (SHC) is typical for this application, single-layer 0.2 mm (SHF) is also available. The degree of protection required for the downstream process and the plugging characteristics of the fluid will guide this selection. Choice should be based on small-scale testing.

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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