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Vaccines - Mammalian Cell

Cell Harvesting

Essential Process Requirements

• Remove heavy solid loads from bioreactor fluid and recover product in filtrate
• Requires high capacity
• Wide feed stream variability depending on cell culture type and conditions
• If solid content is too high, centrifugation becomes preferred technology

Recommended Filter	Filter Characteristics
» Prostak Open-Channel Modules with Durapore 0.22 µm Membrane	Best suited for large bioreactors >1,000 L or bioreactors with high usage rates of more than 10 batches/year Open-channel design accommodates fluids containing low to medium density and solids High flux at low transmembrane pressure Robust construction allows multiple use Validated for multiple SIP cycles Although Durapore 0.22 µm membrane is typical for this application, Prostak Modules are available in with a wide range of membranes 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.
Double-layer Millistak+ HC Filters (Grade D0HC or C0HC) » Disc Filters » Pod Filters	Best suited for large bioreactors >1,000 L or bioreactors with high usage rates of more than 10 batches/year Open-channel design accommodates fluids containing low to medium density and solids High flux at low transmembrane pressure Robust construction allows multiple use Validated for multiple SIP cycles Although Durapore 0.22 µm membrane is typical for this application, Prostak Modules are available in with a wide range of membranes 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.

Clarification or Polishing (Post TFF or Centrifuge)

Essential Process Requirements

• Remove cell debris, small particles and colloids passed through the primary clarification step
• Potential for variations in fluid particle size distribution
• Must have high capacity and protect downstream sterilizing-grade filters

Recommended Filter	Filter Characteristics
Triple-layer Millistak+ HC Filters (Grade B1HC) » Disc Filters » Pod Filters	Ideal solution post-centrifuge for medium and small volume bioreactors with <2,000 L volume Triple-layer configuration includes a membrane bottom layer to enhance filter loading capacity and retention High filtrate quality allows smaller size requirements for downstream sterilizing-grade filtration step Unique design enables the compression of multiple process steps into one, lowering overall filtration costs.
Double-layer Milligard Filters (Grade SS, 0.5 µm + 0.2 µm) » Cartridge Filters » Opticap Capsule Filters » Optiscale Capsule Filters	Ideal solution post-TFF when additional clarification of whole cells and colloids is needed Double-layer pleated configuration increases particle and colloid loading capacity Mixed esters of cellulose filter material with low protein-binding characteristics Low extractables and non-fiber releasing High flow rate at low pressure drop Validated for multiple SIP cycles Decades of proven performance protecting membrane filters 100% integrity tested to ensure quality

Bioburden Reduction

Essential Process Requirements

• Reduces bioburden at intermediate process step
• Protects downstream filters, media and equipment
• Preserves product purity
• Sterilizing-grade filtration required

Recommended Filter

Filter Characteristics

Double-layer Millipore Express SHC 0.5 µm + 0.2 µm Filters » Cartridge Filters » Opticap Capsules

Sterilizing-grade PES 0.2 µm membrane with an additional 0.5 µm prefilter layer all in one pleated device Designed for bulk intermediate processing where fluids may be fouling in batch sizes ranging from 100 to 20,000 L. PES membrane provides 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

Concentration and Diafiltration (Prior to column chromatography steps)

Essential Process Requirements

• 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

Filter Characteristics

» Pellicon C Screen Cassettes with Ultracel PLC 100, 300 or 1,000 kD Membrane

Low feed flow requirements minimize 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)

Essential Process Requirements

• 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

Filter Characteristics

» Pellicon C Screen Cassettes with Ultracel PLC 100 or 300 kD Membrane

Low feed flow requirements minimize 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

Essential Process Requirements

• Sterilizing-grade step to reduce bioburden or sterilize heat labile products
• Highly validated and reliable technology
• Preserves product purity
• Ensures product safety

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 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-layeror multi-layer configurations to accommodate the needs of each user. Choice should be based on small-scale testing.

Product News & Releases

• Millipore Introduces New Service Offer for Evaluating Mixing Solutions
• Millipore Introduces Bench Top TFF System for Process Development at INTERPHEX 2008
• Millipore Introduces Material Certificate Search Application for NovAseptic® and NovaSeptum® Products
• Millipore Launches ProSep® Ultra Plus Affinity Chromatography Media for Antibody Purification

Regulatory Links

• 
• Center for Disease Control
• Federal Drug Administration (FDA)
• EMEA
• World Health Organization
• Pandemic Flu
• Avian Flu