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Alnylam Establishes Team to Apply RNAi to Biologics Manufacturing

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Alnylam Pharmaceuticals last week announced that it has established an internal effort to apply its RNAi technologies to improve biologics manufacturing.

Dubbed Alnylam Biotherapeutics, the effort focuses on using RNAi to “improve the quantity and quality of biologics manufacturing processes using mammalian cell culture, such as Chinese hamster ovary cells,” the company said.

Alnylam said that it has developed proprietary delivery lipids that enable the efficient transfection of siRNAs into CHO cells when grown in suspension culture, noting that studies have shown silencing certain target genes involved in certain CHO cell apoptotic and metabolic pathways led to a 40 percent to 60 percent improvement cell viability as compared with untreated cells.

During the company’s R&D day held last week, Stuart Pollard, vice president of scientific and business strategy, said that the current market for biologics, including recombinant proteins and monoclonal antibodies, “approaches $100 billion worldwide.”

And with about 6,000 biologic products in development across the industry, “the demands of production are both, in terms of efficiency as well as policy, is ever more pressing,” he said. “So we see there's tremendous opportunity broadly in biologics to improve protein production … whether it's for approved products on the market [or] products in development.”

Specifically, Alnylam anticipates that its RNAi expertise may be useful in improving the efficiency and scope of biologics manufacture, while reducing costs and cycle time. “And beyond that … there are opportunities to create enhanced efficacy [and] reduced immunogenicity” of the drugs themselves, he said.

“The concept here is really to leverage RNAi and small biologic manufacturing, and ex vivo application of production cell lines such as the Chinese hamster ovary cell,” Pollard said. “The approach we're taking in this space is to have a small team at Alnylam, which is in place to develop the approach,” and later strike partnerships with pharmaceutical and biotech firms, as well as manufacturers.

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