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Viral Vectors


Viral Vectors

Virus Barrier

Essential Process Requirements

  • 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, Merck suggests using in series with the Viresolve® Prefilter

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Clarification

Essential Process Requirements

  • 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.

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Bioburden Reduction

Essential Process Requirements

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

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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
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.

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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
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.

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Sterile Filtration

Essential Process Requirements

  • 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.

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News

28-jun-2016
Merck to Develop Next-Generation Purification Processes with International Vaccine Institute

Merck has entered a research agreement with the International Vaccine Institute (IVI) of Seoul, South Korea to help develop more robust, scalable vaccine manufacturing processes.

20160628 Medicamentos de molécula pequeña,Fabricación biofarmcéutica
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