Nitto Denko and antisense specialist Isis Pharmaceuticals have jointly developed a new solid support for the manufacture of oligonucleotides that promises to reduce the high manufacturing costs for this type of drug.
Solid support is the base structure used in the synthesis of oligos, including antisense (both RNA and DNA-based), the newer, much-touted RNA interference-based drugs, and aptamers (double stranded DNA or single stranded RNA molecules) and represents a substantial portion of the cost to manufacture these drugs.
The new polymer-based solid support has the potential to decrease manufacturing costs in two ways, according to Isis and Nitto Denko. First, it is less expensive than currently used solid supports. Second, it has the potential to increase yield, thereby further reducing cost-of-goods.
Nitto Denko designed and engineered the solid support, and in collaboration with Isis it was then tested for oligonucleotide synthesis. The product will be marketed by Kinovate Life Sciences, a wholly owned subsidiary of Nitto Denko based in the US, and Isis will receive royalties on sales. Kinovate's first product, CytoPure, a biodegradable polymer transfection reagent was launched soon after the company's inception in January of this year.
The new product "is an important component in our strategy to encourage and facilitate the biotechnology industry's interest in RNA-based technologies," said Lynne Parshall, Isis; chief financial officer.
Manufacture of oligonucleotide drugs involves use of solid support matrix upon which chemical reactions happen in a cyclic manner. The reactions are performed in a synthesiser and are fully automated. At the end of synthesis, drugs are purified by high performance liquid chromatography (HPLC) and characterised extensively to check their authenticity and purity.
Solid support plays a crucial role in the manufacture of oligonucleotide drugs, and it is increasingly believed that the yield of an oligonucleotide synthesis is greatly influenced by the proper design of a polymeric support which undergoes roughly eighty chemical reactions in about eight hours for a 20-mer oligonucleotide.
Nitto Denko's Kenji Matsumoto said the new material material has shown superior performance to rival products in both small and large scale synthesis.