Although the targets of biomanufacturing have evolved from therapeutic proteins to “advanced therapies” and now to gene therapies, the issues and solutions remain the same. The production of safe, effective medicines is achieved by means of controlled, well-characterized processes. So, while the therapeutic vehicle has changed (from a protein to a virus-delivered gene), the roles of process development and supporting analytics have not.
Today’s viral vector manufacturing faces much the same challenge that conventional protein biomanufacturing faced 30 years ago. Essentially, the challenge is to develop robust, well-characterized processing steps supported by rapid, reliable, high-throughput, and equally robust analytical methods. The top consideration for any virus production process is ensuring consistent product quality through scaleup, says William Lee, PhD, research associate, Alexion Pharmaceuticals (a subsidiary of AstraZeneca).
“Careful addition of the DNA complex to the bioreactor is one key scaleup factor that affects product quality,” he emphasizes. “We use advanced analytical methods, such as multiattribute long-read next-generation sequencing, and two separate potency assays to mitigate the potential for quality impact from modifying the upstream process.” Switching adeno-associated virus (AAV) manufacturing from adherent-cell platforms to suspension-cell platforms has been a high priority.
Suspension-cell systems are easier to treat, feed, character.
