New empty/full method to enable robust manufacturing of AAV products
s
Oct
12
2023
On demand

New empty/full method to enable robust manufacturing of AAV products

Thursday 08:00 PDT / 11:00 EDT / 16:00 BST / 17:00 CEST
Sponsor
New empty/full method to enable robust manufacturing of AAV products

Separation of empty and full AAV capsids with almost identical chromatographic characteristics requires very high-resolution chromatography media and scale-to scale reproducibility within just few percent. Qualification of chromatographic columns using small molecules might be misleading when separation of large molecules or virus particles is in question. Column release criteria based on the AAV elution profile therefore need to be adopted and used for all column sizes.

Recently, the presence of partial and heavy AAV capsids in gene therapy products has attracted more attention due to potential carry-over of the host cell (hc)DNA and plasmid DNA fragments. Their removal from the product is therefore becoming crucial.

To address this important need, Sartorius BIA Separations developed the new CIMmultus HR (high reproducibility) columns, with better resolution and narrower acceptance criteria. These columns allow for batch-to-batch and scale-to-scale reproducibility within just 3% of the AAV8 empty capsid isoconductivity elution. Such columns allow for step gradient elution using the same buffer strength at any scale. Two orders of magnitude removal of empty capsid should be possible at any scale.

Attend this webinar to learn more about:

  • Achieving better resolution of empty/full capsids and large-scale removal of empty, partial and heavy AAV capsids
  • The product release criteria of new CIMmultus HR columns, based on the elution of empty AAV8 capsid
  • Attaining batch-to-batch and scale-to-scale reproducibility within +/- 3%
Aleš Štrancar
Aleš Štrancar
Managing Director of Sartorius BIA Separations

Ales Štrancar has been the Executive Managing director of Sartorius BIA Separations since it was founded in 1998. Aleš is one of the main inventors of the CIM Convective Interaction Media® monolithic columns technology and co-inventor of many analytical methods including pDNA, mRNA, AAV, Adeno and other viruses. He also co-developed a number of DSP processes including pDNA for Boehringer Ingelheim and AAV for AveXis/Novartis.

Aleš is author or co-author of more than 100 scientific papers dealing with separation and purification technologies. He is a co-author of several granted patents.