The SK pharmteco group is now offering a standardized viral vector and plasmid manufacturing process to a global audience. The global approach can help customers move to batches for clinical trials in 12 months, rather than 20 months for a standard approach, according to Adrien Auffret-Cariou, team lead process development projects at Yposkesi, a SK pharmteco company.
Auffret-Cariou, who recently gave a talk at the Terrapinn conference on Advanced Therapies, says the new global approach offers both speed and savings.
“When we make a proposal, it’s global, and we can be fast because we have analytical facilities in the United States and in Europe—because there are analytics to perform on every batch,” he explains, adding that the global approach overcomes the problems of using multiple external suppliers for production and analytics.
“Sometimes it’s difficult [with an external supplier] to have the right slot for this type of testing, so we can reduce the time to validate the batch with [a planned, global] approach,” he says.
Offered to the global audience is AAVelocity™, a standardized scalable approach to manufacturing adeno-associated viruses (AAV) at up to 1,000 L in suspension. Also available is Lentisure™ for scalable lentivirus production up to 200 L, dependent on process, along with plasmid production and a dedicated cell line if customers require this. LentiSure and AAVelocity were developed by Yposkesi, an SK pharmteco company.
“In France, we are specialized in viral vector manufacturing. And in the United States, we have a facility that performs viral vector manufacturing but also plasmid production and cell therapy, and everything has been developed to be cost effective and time effective for customers,” continues Auffret-Cariou.
Instead of going to a separate plasmid manufacturer, he says, customers benefit from a single source.
“We control all the parts of this manufacturing. Planning is very critical for moving to the clinic. If we have fewer suppliers, we can move faster because we can plan slots for every step,” he explains, noting that this helps tackle challenges facing the gene and cell therapy industry because of current difficulties securing investment. “[Companies] don’t have much time to get to clinic, so—to be as fast as they can—we’ve proposed this platform,” he says.
