Pharma Focus Asia
Klöckner Pentaplast - Pentapharm® alfoil® films

SCIEX Launched Breakthrough Method for Gene Therapies

SCIEX has launched an exciting new and innovative capillary electrophoretic method for streamlining and improving the production of gene therapies.

By analyzing Adeno-associated viruses(AAVs) to determine whether the therapeutic transgene payload has been successfully incorporated into the AAV vector product, this new technique addresses the main customer challenge.

During the manufacturing of AAV vectors, capsids containing the full payload of transgenes are created along with a high percentage of capsids that might not include any of the transgenes (empty), or contain fragments of the transgene (partial).The existence of these impurities could increase immunogenicity or restrain thetransduction of full capsids by competing for vector binding sites on cells.

Successful incorporation of the transgene is necessary for the efficacy and safety of gene therapies. The ability to quickly determine capsid payload utilising sample amounts will help drug developers increase their time to market, as well as deliver a safe and effective product.

Whether the AAV capsids are full, partially full, or empty,this new analytical method is able to detect with great accuracy. Key attributes include:

  • A platform method that can be optimised for the separation of full, empty and partial capsids in AAV samples across multiple serotypes
  • High resolving power: separating full and empty AAVs with very small isoelectric point (pI) differences of ≤ 0.1 pH unit
  • Quick analysis time: less than 1 hour per sample
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