Vaccines - Viral Vectors

Virus Barrier

• Removes adventitious viruses
• Ensures product safety
• Requires a highly validated and reliable technology
• Maximizes product recovery
• Preserves and ensures product purity

Recommended Filter

, Viresolve NFP Filters Filter Requirements >4 log removal of parvovirus and other small viruses without compromising flow rate or removing vital media nutrients Robust PVDF membrane >98% protein recovery up to 160 kD Available in multiple formats for easy scale-up and scale-down 100% Integrity testing assures performance Can be integrity tested on-site Can be integrity tested on-siteTo ensure performance and capacity, Millipore suggests using in series with the Viresolve Prefilter

Clarification

• Removes cell debris, small particles and colloids after the cell lysis step
• Must have high throughput capacity
• Protects downstream sterilizing-grade membrane filters

Recommended Filter

Single-layer Millistak+ CE Filters (Grade 40CE, 45CE, or 50CE)         Disc Filters :: Opticap Capsule Filters Filter Requirements Better suited for volumes <2,000 L High internal surface area for maximum particle capture loading Filter matrix exhibits positive charge properties to enhance filtration High porosity provides low pressure drop Available in several media grades 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.

Bioburden Reduction

• Reduces bioburden
• Protects downstream chromatography and UF/DF steps
• Preserves product purity

Recommended Filter

Double-layer Durapore 0.45 µm Filters (with 0.5 µm prefilter layer)         Cartridge Filters :: Optiseal Cartridge Filters :: Opticap Capsule Filters Filter Requirements Low protein-binding PVDF membrane with prefilter layer Highly retentive membrane reduces bioburden Low extractables and non-fiber releasing PVDF chemistry preserves product purity and yield High flow rate at low pressure drop for reliable economic processing 100% integrity testing and thousands of applications assures proven performance Validated for multiple SIP and hot water sanitization cycles

Concentration and Diafiltration
(Prior to column chromatography steps)

• Concentration of process fluids and buffer exchange
• Will extend the life of expensive chromatography media and improve their speed and efficiency
• Fast, robust process able to accommodate feed fluid variations
• Wide chemical compatibility with cleaning agents
• Easily scalable from lab to manufacturing scale

Recommended Filter

Pellicon V Screen Cassettes with Ultracel PLC 300 kD Membrane Filter Requirements 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 Ultracel PLC membranes assure consistent processing from batch to batch, have good chemical compatibility and are easy to clean Complete range of devices for easy scale-up Choose a membrane molecular weight cut-off 3–5X smaller than the biomolecule. Choice should be based on small-scale testing.

Concentration and Diafiltration (For final formulation)

• Concentration and diafiltration adjusts the end product to the proper dosage conditions prior to final packaging
• Fast, robust process able to accommodate feed fluid variations
• Easily scalable from lab to manufacturing scale

Recommended Filter

Pellicon C Screen Cassettes with Ultracel PLC 300 kD Membrane Filter Requirements Low feed flow requirement minimizes pumping, working and hold up volumes Higher product recovery and flux Highly retentive regenerated cellulose membranes offer good permeate flux and withstand process upsets Robust low binding void-free Ultracel PLC membranes assure consistent processing from batch to batch, have good chemical compatibility and are easy to clean Complete range of devices for easy scale-up Choose a membrane molecular weight cut-off 3–5X smaller than the biomolecule. Choice should be based on small-scale testing.

Sterile Filtration

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

Recommended Filter

Durapore 0.22 µm Filters        Cartridge Filters :: Optiseal Cartridge Filters :: Opticap Capsule Filters :: Optiseal Capsule Fitlers Filter Requirements Low protein-binding sterilizing-grade PVDF membrane Low extractables preserve product purity and yield High flow rate at low pressure drop for reliable economic processing 100% integrity testing and thousands of applications assure proven performance Validated for multiple SIP and hot water sanitization cycles Available in Millipak stacked disc format which allows minimal hold-up volume Although 0.22 µm membrane 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. Choice should be based on small-scale testing.