As an RNA duplex progresses from discovery phase to the clinic several hundred grams of the duplex, manufactured to GMP standards, need to be sourced over the lifetime of the trials. “Since 1999, Avecia Biotechnology has been a supplier of GMP oligonucleotides,” reports Kevin Fettes, process development group leader.
“Recently, as the therapeutic potential of RNAi has become established, the demand for GMP materials to be used in clinical trials has increased,” Fettes says. “My presentation will discuss the technology used to manufacture RNA duplexes and considerations that need to be addressed as demand for the duplex increases throughout clinical trials and as process validation and commercial launch approach,” he says.
Avecia recently installed new large-scale high-pressure purification equipment for RNA/aptamers and the capacity to manufacture hundreds of kilograms of commercial product per year, according to Fettes. “The objective of our process-development group at Avecia is to provide efficient, robust, and scalable processes that can be used for clinical manufacture, process validation, and beyond,” he adds.