BIA Separations selected for manufacturing process development support for gene therapy pipeline

Posted on by zymecom

  • BIA Separations will provide expertise in next generation biomolecule purification processes and long-term supply of CIMmultus™ monolithic columns
  • Initial focus on the manufacture of Zolgensma®, a gene therapy for pediatric patients with spinal muscular atrophy (SMA) less than the age of 2

Ajdovšcina, Slovenia, 22nd July 2019: BIA Separations, a leading biochromatography development and manufacturing company, today announced it is collaborating with AveXis, a Novartis company, to enhance the commercial purification process for its gene therapy pipeline, beginning with Zolgensma® (onasemnogene abeparvovec-xioi), the first U.S. Food and Drug Administration-approved gene therapy indicated for the treatment of pediatric patients with spinal muscular atrophy (SMA) who are less than two years of age.

Zolgensma is a one-time infusion that provides a functional copy of the human SMN gene to halt disease progression through sustained SMN protein expression.

BIA was selected as a result of its expertise in viral and DNA purification, particularly adeno-associated virus (AAV), and chromatographic technology for the purification and analysis of biomolecules.

Aleš Štrancar, CEO of BIA Separations commented: “We are proud to have been selected to support AveXis’ gene therapy pipeline. We look forward to seeing how Zolgensma helps the SMA community and the whole BIA team is honored to be a part of this important work.”

Andy Stober, Senior Vice President of Technical Operations for AveXis added: “We are especially grateful that BIA Separations shared, and operated, with the same sense of urgency we did to help bring gene therapy to the SMA community. BIA’s experience with AAV purification and its chromatographic technology were important contributions and we look forward to our continued work together.”



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