Chinese drugmaker General Biol has chosen Cytiva’s single-use Flex-Factory platform to support oligonucleotide production.

The deal, of which financial details have not been disclosed, sees Cytiva provide General Biol with its integrated FlexFactory single-use  platform. This includes an OligoProcess nucleic acid synthesis system, ÄKTA Process explosion-proof purification system, and a Uniflux explosion-proof tangential flow ultrafiltration system.

“A FlexFactory is a biomanufacturing platform that supports different types of manufacturing processes,” a spokesperson for Cytiva told us.

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“It is configurable with respect to equipment, automation and service levels. Cytiva’s FlexFactory for General Biol is the first end-to-end, configurable biomanufacturing platform that supports oligonucleotide manufacturing.”

According to Cytiva, the Oligo FlexFactory will drive General Biol’s oligonucleotide contract development manufacturing organization (CDMO) business by providing customers with process development support, optimization, formula development, pilot production services, and customized manufacturing services.

“Oligonucleotides are synthetic strands of DNA or RNA that can be used as therapies or diagnostics by binding to a target gene or protein sequence. The fast-growing oligo therapeutics market includes highly targeted antisense DNA and small interfering RNA (siRNA), and it is growing in promise for treating cancers, genetic diseases, and other conditions,” a spokesperson for Cytiva told BioProcess Insider.

Cytiva said the production yield for oligonucleotides has “become a bottleneck in their commercialization” because of requirements for large drug doses and limitations in the existing delivery systems.

Two phases

The project has two phases. The first phase consists of the construction of a pilot scale production line as well as two additional lines with an annual capacity of several hundred kilograms. The second phase involves the construction of two more production lines, which have similar annual capacity output and is expected to be finished by the end of this year.

The AnHui factory will manufacture several hundred kilograms of pharmaceutical oligonucleotide a year to meet the needs of different oligonucleotide production scales. And Cytiva claims that “compared with small molecule and monoclonal antibody (mAb) therapeutics, oligo drugs have unique advantages as they have a faster development time, a simpler bioprocessing workflow, higher success rate, and broader therapeutic applications.”

General Biol will be responsible for staffing the factory.