Vaccines - Conjugates

Concentration and Diafiltration
(Prior to additional purification)

• Concentration and diafiltration of conjugate prior to reacting with the polysaccharide assures the proper formulation and conditions
• 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 100, 300 or 1,000 kD Membranes Filter Characteristics 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

Bioburden Reduction

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

Recommended Filter

Double-layer Multilayer Durapore 0.45 µm + 0.22 µm Filters       Cartridge Filters :: Opticap Capsule Filters :: Optiscale Capsule Filters Filter Characteristics Sterilizing-grade PVDF 0.22 µm membrane with an additional 0.45 µm prefilter layer all in one pleated device Low-binding membranes assure product yield and sterility 100% Integrity testing ensures quality Double-layer construction provides excellent capacity and protection of downstream equipment Can be integrity tested on-site

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 30, 100, 300 or 1,000 kD Membranes Filter Characteristics 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.

Sterile Filtration

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

Recommended Filter

Durapore 0.22 µm Filters       Cartridge Filters :: Optiseal Cartridge Filters :: Opticap Capsule Filters :: Optiseal Capsule Filters Filter Characteristics Low extractables preserve product purity and yield Low protein-binding sterilizing-grade PVDF membrane 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.