Gene therapy specialist and Lonza forge production pact
pharmafile | May 22, 2012 | News story | Manufacturing and Production |Â Â Avalanche, Lonza, Phil TaylorÂ
Avalanche Biotechnologies, a US company developing gene therapies for ocular diseases, has signed a manufacturing collaboration with Lonza of Switzerland.
In addition to producing Avalanche’s in-house drug candidates, the two companies will also make the production technology available to third parties and share in revenues. The agreement will focus on process development and scale-up efforts for the manufacturing of adeno-associated viral (AAV) vectors for gene therapy.
Lonza is already a major player in viral vaccine and viral vector biologics, with a facility in Houston, Texas, that covers process development, production, purification and fill-and-finish, as well as providing analytical services, storage and distribution.
The Avalanche and Lonza collaboration will focus on the development and high-yield AAV production based on a novel technology that uses a stable baculovirus expression system to produce AAV vectors in insect cells under serum-free conditions.
This technology was licensed by Avalanche from Virovek, which will also play a key role in the collaboration, according to the partners.
“Lonza’s viral-based therapeutic business specialises in the development, GMP production, and fill and finish of multiple classes of viral vaccines and viral vector-delivered therapeutics,” commented David Enloe, head of viral-based therapeutics at the contract manufacturer.
“With our recent expansion of additional GMP suites that will increase working volumes up to 2,000L, we are poised for the growth we have seen in this sector,” he added.
Avalanche said AAV vectors are a promising gene delivery vehicle for the treatment of various diseases including inherited retinal disorders, age-related macular degeneration (AMD), haemophilia B, congestive heart failure, Parkinson’s disease and others.
The company’s lead in-house project is AVA-101, a treatment for the wet form of AMD that uses an AAV vector to deliver a gene coding for recombinant anti-VEGF protein into the eye.
The ‘Ocular BioFactory’ continuously secretes a therapeutic protein over an extended period, avoiding the need for frequent intraocular injections of recombinant anti-VEGF protein, which is the active ingredient in AMD treatments such as Roche/Genentech’s Lucentis (ranibizumab) and Regeneron’s Eylea (aflibercept).
Phil Taylor
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