Chromatography - Monoclonal Antibodies

A Monoclonal Antibody purification typically has three chromatographic steps: Capture, Intermediate Purification, and Polishing. Pall offers process chromatography sorbents for each chromatographic step. (Select a step below for more information.)

Capture Chromatography

Produkte Benefits/Differentiation Additional Resources

MEP Hypercel™ Sorbents 
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  • An economic alternative to Protein A sorbents.
  • Elution is conducted under relatively mild ionic strength, resulting in a reduced need for dilution or diafiltration if IEX is the following step.
  • Elution is at moderate pH, preserving antibody integrity and reducing the chance of aggregation.
  • Robust sorbent can withstand standard cleaning protocols using Sodium Hydroxide.
  • Works well with a wide range of antibodies, regardless of species.

CM Ceramic HyperD® Sorbents
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Unique “gel-in-a-shell” Ceramic HyperD sorbents offer:
  • Excellent pressure/flow characteristics and are non-compressible.
  • High binding capacity at high linear velocity (through enhanced diffusion). There is a reduced dependence of DBC on linear flow, which is not the case with traditional IEX sorbents.
  • With CM Ceramic HyperD sorbent, users achieve efficient capture from feedstock of moderate ionic strength (19 mS) and reduce the need for dilution or diafiltration.


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Intermediate Purification

Resolution and selectivity are important to separate closely related contaminants from the target antibody. Typically HIC and/or Cation exchange chromatography are used at this step in a process.

Produkt Benefits/Differentiation Additional Resources

Ceramic HyperD® IEX Sorbents
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Unique “gel-in-a-shell” Ceramic HyperD sorbents offer:
  • Excellent pressure/flow characteristics and are non-compressible.
  • High binding capacity at high linear velocity (through enhanced diffusion). There is a reduced dependence of DBC on linear flow, which is not the case with traditional IEX sorbents.
  • With CM Ceramic HyperD sorbents, users achieve efficient capture from feedstock of moderate ionic strength (19 mS) and reduce the need for dilution or diafiltration.
HEA/PPA HyperCel™ Sorbents
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Offer unique selectivities not seen with traditional IEX or HIC chromatography sorbents. HEA HyperCel and PPA HyperCel sorbents should be evaluated when:

  • Traditional HIC is being evaluated. HEA and PPA will behave like HIC sorbents without the need to add lyotropic salt.
  • The conductivity of the feedstock is too high for a traditional IEX sorbent. This will reduce the need for dilution before loading.
  • New selectivities will help resolve/remove closely-related impurities.


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Polishing

Flow rate is of key importance, less so capacity, as trace levels of contaminants are removed in flow-through mode. Disposable membrane chromatography (Mustang® membrane) is ideal for this step.

Mustang membrane can also be considered for guard column applications where there is a need to remove potential foulants from the feedstream before loading the capture column. The high flow rate capability, good dynamic binding capacity, and disposable format make Mustang membrane an ideal choice for such applications.

Produkt Benefits/Differentiation Additional Resources

Mustang® Q Membrane Products

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Coin Units

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Capsules and Cartridges

  • Target DNA and cell host protein.
  • Flow rate is key driver.
  • No packing or unpacking of a column.
  • Capacity is more than adequate for removal.
  • No cleaning or cleaning validation required.
  • Smaller footprint, saves space.


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