BIA Separations’ prepacked chromatography columns “contribute to a robust manufacturing process” for the recently approved gene therapy Zolgensma, says AveXis.

In May, the US Food and Drug Administration (FDA) approved Zolgensma (onasemnogene abeparvovec), a gene therapy designed to halt progressive spinal muscular atrophy (SMA).

Novartis subsidiary AveXis developed and commercialized the $2.1 million one-off treatment, but – as the saying goes – it takes a village to raise a child. Zolgensma relies on Regenxbio’s adeno-associated virus (AAV) vector technology, and some third-party manufacturing, with Catalent’s Paragon recently named as a CDMO.

Image c/o BIA Separations

And now Slovenian biochromatography development and manufacturing company BIA Separations has been named as contractor of purification technologies for the gene therapy, through the long-term supply of its CIMmultus monolithic columns.

“The BIA technology contributes to a robust manufacturing process, yielding quality drug product,” an AveXis spokesperson told this publication, adding BIA has been onboard throughout the commercial process.

“The use of BIA technology is part of the licensed process that was recently approved by the FDA.”

BIA Monolithic Columns

According to a BIA spokesperson, CIMmultus Monolithic Columns are cGMP compliant, scalable up to 40L and functionalised as IEX-, HIC-, H-Bond-, Affinity- or Activated supports.

“CIMmultus Monolithic Columns were designed such that specifically large, complex products like Viruses (e.g. AAV like Zolgensma), Plasmids, RNA or Exosomes can perfectly be captured and separated from process and product related impurities,” we were told.

“In the field of AAV Therapeutics especially the disruption and elimination of Nucleic Acid-Protein complexes and the separation of full AAV capsids from empty or compromised Capsids are unique technology assets to CIMmultus Monolithic Columns.”