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OXGENE launches a scalable, plasmid-free manufacturing system for AAV

OXGENE launches a scalable, plasmid-free manufacturing system for AAV:

OXGENE™, a biotechnology firm designing and creating scalable gene remedy applied sciences, has right this moment introduced the launch of its scalable, plasmid-free manufacturing system for AAV. OXGENE’s new TESSA™ expertise addresses industry-wide challenges related to sturdy and reproducible AAV manufacture at scale. These embrace the excessive price of products and low packaging effectivity. TESSA goals to ship a paradigm shift in scalable AAV manufacture.

OXGENE launches a scalable, plasmid-free manufacturing system for AAV

OXGENE TESSA™ vectors

Adeno-associated virus, or AAV, is a well-liked selection of viral vector to ship gene therapies to sufferers, owing to its low immunogenicity, favorable security profile and the convenience with which it transduces quite a few cell and tissue varieties. Nonetheless, manufacturing methods haven’t stored tempo with organic advances, leaving these therapies pricey, tough to provide at scale, and topic to inherent batch-to-batch variability. This represents a critical problem to regulators and well being authorities in the case of approving these remedies for medical use.

OXGENE’s TESSA expertise overcomes manufacturing obstacles by making the most of AAV’s pure relationship with one other virus — the adenovirus. In nature, AAV co-exists with adenovirus, which gives the ‘assist’ AAV wants to duplicate. Nonetheless, in addition to replicating the AAV, the adenovirus additionally replicates itself, resulting in excessive ranges of adenoviral contamination if this course of is translated to an industrial context.

OXGENE has addressed these challenges by manipulating the adenoviral life cycle in order that it will possibly nonetheless present top quality assist for AAV replication, however is unable to fabricate itself, decreasing adenoviral contamination by 99.9999% in a producing run. Integration of the AAV rep and cap genes into the adenoviral vector implies that every thing required for AAV manufacturing, besides the AAV genome, might be supplied in a single viral vector. In the meantime, the AAV genome can both be encoded inside a second TESSA vector, in a plasmid, or inside an AAV particle itself. Utilizing two TESSA vectors improves yields of AAV2 by 40-fold, accompanied by a 2000-fold improve in particle infectivity in comparison with a regular three-plasmid manufacturing strategy.

As soon as this primary AAV seed inventory has been produced, co-infecting cells with this AAV alongside one other TESSA vector can additional amplify the AAV in a easy, reproducible and scalable method, eradicating the reliance on costly and limiting plasmids for AAV manufacture.

The gene remedy {industry}’s reliance on plasmids is a serious limitation for sturdy and reproducible large-scale AAV manufacture. By taking a ‘again to nature’ strategy to rethink AAV manufacturing from the bottom up, we’ve developed a very modern new expertise that we count on to remodel the best way AAV is manufactured. By combining excessive AAV yields with scalability, packaging effectivity and elevated infectivity, we hope that TESSA expertise will assist to deliver down the general price of products concerned in gene remedy growth. We hope it’ll additionally enhance the protection of the ultimate therapeutics, as the upper high quality, extra infectious AAV ensuing from TESSA based mostly manufacture may imply considerably decrease efficient doses.”

OXGENE’s CEO, Dr Ryan Cawood

OXGENE has to date developed and validated TESSA vectors for AAV2, 5, 6 and 9 and is now taking requests for service tasks and product pre-orders to additional develop and consider this expertise.

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