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Plasmid DNA


Plasmid DNA

Clarification & Solids Removal (In Place of Bag Filter)

Essential Process Requirements

  • Remove solids after the cell lysis step
  • Have high debris holding capacity
  • Protect downstream membranes
  • Charged medias should be avoided due to plasmid interaction
  • Typically operated at low delta P to minimize precipitate or breakthrough
  • Process is more efficient in cases of flocculants that float
  • Washing of precipitate to reduce endotoxin and genomic DNA contaminants
Recommended Filter
Polygard® CR 10 µm Filters
Cartridge Filters :: Opticap® Capsule Filters

Filter Requirements

  • For use in place of a bag filter or for extra clarification after cell lysis
  • Multi-stage graded density design retains solids or sediment within the depth matrix
  • Polypropylene media provides excellent solids capacity and high throughput.
Clarigard® 0.5 µm Filters
Cartridge Filters :: Opticap® Capsule Filters

Filter Requirements

  • For use in series after the Polygard® CR filter when no bag filter is used for solids removal
  • Polypropylene graded density prefilter for robust particle and colloid removal
  • 1–2 log bioburden reduction
  • Validated for multiple sanitization and SIP cycles
  • Higher filtrate quality allows smaller size requirements for downstream sterilizing-grade filtration step
  • Non-fiber releasing structure preserves product purity.

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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 30 or 100 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 30 or 100 kD Membranes

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.

ALTERNATIVE: In case of high concentrations (>5 g/L) Pellicon V Screen cassettes are recommended.

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Sterile Filtration

Essential Process Requirements

  • Sterilizing-grade step removes bacteria prior to aseptic fill
  • Ensures product safety
  • Highly validated and reliable technology
  • Preserves product purity

Note: Membrane chemistries other than PES are known to cause gel formation at the membrane surface. We strongly recommend a PES filter for this step.

Recommended Filter
Double-layer Millipore Express® SHC 0.5 µm + 0.2 µm Filters
Cartridge Filters :: Opticap® Capsules :: Optiscale® Capsules

Filter Requirements

  • Sterilizing-grade PES 0.2 µm membrane with an additional 0.5 µm PES prefilter layer all in one pleated device
  • Double-layer construction provides excellent capacity even in high salt conditions
  • 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 PES pore structure delivers extremely high flow rates at low pressure drop
  • Can be integrity tested on-site

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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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