Ribobay Pharma to start production of cGMP-level oligonucleotide

Published: 18-Sep-2024

China-based Ribobay Pharma is using Cytiva’s FlexFactory platform for oligo manufacturing to provide cGMP-level oligonucleotide (oligo) CRDMO services to its global clients

Ribobay Pharma, a Chinese biopharmaceutical contract research, development, and manufacturing organisation (CRDMO), will provide cGMP-level oligonucleotide (oligo) CRDMO services globally using Cytiva’s first FlexFactory platform for oligo manufacturing.

Cytiva's first FlexFactory platform is a modular biomanufacturing solution designed to provide a flexible and scalable production system for biopharmaceutical manufacturing.

Further, the wholly-owned subsidiary of General Biol, Ribobay Pharma, started manufacturing in June and expects to produce several hundred kilograms of pharmaceutical oligo per year, bringing increased reliability, speed, and efficiency to the development of novel therapies.

In addition, General Bio is a biotechnology company that offers its global clients a one-stop shop for raw materials for bio-innovative medication research and development, as well as basic life science research.

Ribobay Pharmaceutical focuses on the field of medicinal oligonucleotides CXO, which is one of the important layouts for General Biol's CXO business expansion.

General Manager of Ribobay Pharma, Jingui Yong, said: “With the support of Cytiva, we will rapidly expand our oligo CRDMO business by manufacturing high-quality and diversified innovative drugs, as well as new vaccine adjuvant (CpG-ODNs) for global customers. We look forward to building on synergies and creating more value with our collaborators.”

The collaboration between Cytiva and Ribobay Pharma is an agile response to market needs and developmental bottlenecks

In particular, they can provide process development support, optimisation, method development, pilot production services, and customised manufacturing services.

The collaboration between Cytiva and Ribobay Pharma is an agile response to market needs and developmental bottlenecks.

Cytiva provides Ribobay Pharma with one-stop integrated services, from factory design to equipment and technologies that enable cGMP manufacturing.

Allen Li, President of Cytiva in China, said "It's an honour to work with Ribobay Pharma to roll out our very first FlexFactory platform for oligos. We will continue facilitating more Chinese companies to navigate the global market, and ultimately help improve the accessibility of life-changing therapies for global patients."

Flex Factory project

At the end of 2021, Ribobay reached strategic cooperation with Cytiva, a US-based supplier of oligonucleotide production equipment, to build the world's first Flex Factory factory, achieving hundreds of kilograms of GMP-grade oligonucleotides. 

The project has multiple oligonucleotide production lines such as OligoPilot and OligoProcess. 

Ribobay Pharma started manufacturing in June and expects to produce several hundred kilograms of pharmaceutical oligo per year

The single batch production scale can be up to 1.8 mol. The flexible modular process unit setting can meet the needs of multi-type oligonucleotide production. 

The production line operates independently and can meet the needs of multiple projects simultaneously.

Oligo drugs

Due to their rapid development cycle, impressive success rate, low side effects, and lasting effectiveness, oligo drugs are now being applied far beyond rare diseases.

Oligo drugs are tackling chronic conditions like hyperlipidemia, hepatitis B, and diabetes, with over 1500 research pipelines around the globe.

Ribobay Pharmaceutical focuses on the field of medicinal oligonucleotides CXO

However, turning oligo drugs into commercially available products requires technology accumulation and validation, presenting high barriers in quality control and production processes. Due to the lack of industrialisation and factory construction experience, large-scale production faces considerable challenges.

 

Top image: Ribobay Pharma’s site in Anhui, China for oligonucleotide production

 

 

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