CIMmultus® QA HR 4000 mL cGMP Compliant Monolithic Column (2 μm)

CIMmultus^® QA HR line is a new generation of pre-packed chromatographic monolithic products developed to meet the most demanding separation and purification needs. HR stands for High Reproducibility between batches and different scales.

CIM^® QA HR line includes all standard CIM^® column scales: CIMmultus for preparative applications, from 1 mL to 8 L, as well as CIM^® QA HR 96-well plates, analytical CIMac™ QA HR columns and industrial 40L CIMmultus QA HR columns. In combination with the novel QA methods, outstanding separation of different AAV capsids for the enrichment of full AAV capsids should be possible at any scale.

The new CIM^® QA HR line features the same quaternary amine (QA) ligand as the standard CIM^® QA columns but implements an additional specialized testing procedure with strict release criteria. Acceptance criteria of the CIM^® QA HR are based on the conductivity values of the empty AAV capsids elution, instead of the ion capacity test using small ionic molecules applied for the standard CIM^® QA.

As the production methods are the same, the quality assurance regulatory support file for the QA HR cGMP columns is also the same as for the standard QA cGMP product line. This allows users of CIMmultus^® QA cGMP compliant columns a smooth transition from the standard CIMmultus^® QA line to the new CIMmultus^® QA HR line.

QA HR (quaternary amine) features:

• Strong anion exchanger
• Binds molecules with a predominantly negative charge, repels molecules with a predominantly positive charge
• Use for polishing steps in either bind-elute or flow-through mode.
• Column release criteria based on the AAV8 elution profile
• Selected to meet the need for highly reproducible purification processes (e.g., separation of AAV empty from AAV full capsids)
• Sanitizable with 0.5 M NaOH

Benefits:

• Very fast processes by convective mass transport – resolution independent of flow
• Ready to use columns
• High-capacity for large molecules due to fully accessible void volume in the channels
• Laminar flow minimizes shear stress resulting in high yields