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- 06/17/2019

RiboBio – Asia’s Leading cGMP Oligonucleotide Manufacturing Partner

Chimica Oggi-Chemistry Today

RiboBio is Asia’s largest oligonucleotide-based drug manufacturer. RiboBio provides flexible, fast and cost-effective oligonucleotide manufacturing services for all phases of development. RiboBio has extensive experience in CMC development and large-scale production. RiboBio can synthesize in scales from nmol to 1800 mmols in a single batch. RiboBio was the first CMC manufacturer in China to receive a license from CFDA to manufacture oligonucleotides for clinical use.

 

RiboBio is Asia’s largest oligonucleotide-based drug manufacturer. Over the years, RiboBio has developed many novel nucleic-acid based technologies utilizing its world-class R&D team equipped with state-of-the-art tools and facilities. Currently, RiboBio develops and supplies innovative RNAi, lncRNA and miRNA products and offers as diverse line of oligonucleotide-based services including CRO, Synthesis and CDMO services from small to commercial scales. Our customers represent thousands from academia, medical, pharmaceutical, industrial and government organizations, both domestic and international.

 

RiboBio was the first licensed cGMP manufacturing facility in China specializing in Oligonucleotide Manufacturing. In its facilities, RiboBio offers a wide-range of synthesis scales for oligonucleotides, from milligram to multi-kilogram, with diverse modifications and chemistries. RiboBio manufactures oligonucleotides for various purposes including; pre-clinical research and toxicology studies, to clinical trials from Phase I to Phase III, and marketed-product commercialization of final API, diagnostic or cosmetic ingredient. To assure the success of our manufacturing projects, we work closely with our clients: from the definition of the projects initial goals through development, including analytical methods development, tox and stability studies, through commercialization and beyond.

 

Environment, Methods, Materials and Validation

RiboBio’s cGMP manufacturing facility meets or exceeds current IS08, IS07 and IS05 requirements as well as ICH Q7(cGMP) and CFDA Title 21 part 210(cGMP) requirements. To ensure RiboBio continues to meet or exceed these requirements, RiboBio conducts continuous and systematic on-going testing of facilities, water and air supplies, major equipment and in-coming raw materials.

  • Validated procedures for the strict qualification of raw materials from reliable, industry-leading suppliers
  • Centralized gas supply with on-site purification systems for air and water
  • Operating procedures for equipment cleaning, sanitization and validation.

 

Experienced Team

  • 15+years of experience synthesizing and manufacturing oligonucleotides
  • Manufactured 1,000, 000+ molecules, with a variety of modifications
  • Recognized as top supplier of “specialty” oligonucleotides
  • Highly trained personnel(BS, MS, PhD), and experienced project managers
  • Successfully completed Many projects

 

Advanced Instruments

Ribobio manufactures oligonucleotides using comprehensive, most advanced and updated synthesis, purification and, ultrafiltration, lyophilization analytical equipment.

  • Synthesis: ÄKTA OP 100 ÄKTA OP 400, Oligo Process 1800 mmol Synthesizers
  • Purification: ÄKTAexplorer, ÄKTApilot and ÄKTAprocess
  • Desalting: ultra-filtration skids from
  • Lyophilization: from 0.5 ~ 7.5m2
  • Sterile Fill and Finish

We provide One – Stop solution for Oligonucleotide from grams to kilograms under internationally accepted GMP standards and practices.

 

Process Development

Your oligonucleotide manufacturing project is considered unique requiring an individual approach. Therefore, we work closely with

you to have a detailed technical discussion to optimize your process, before starting full scale production. Process optimization

assures you an oligonucleotide manufactured with the highest yield and purity while minimizing costs.

 

Project Management

Ribobio’s utmost goal is Customer’s satisfaction. To achieve this goal we make all reasonable efforts to establish mutually acceptable and achievable project goals with timelines and milestones and success metrics.

  • Strict timelines
  • Unsurpassed recovery, high purity, low cost
  • Consistent, Scalable, Performance from research to production
  • Process reliability and reproducibility
  • Protocol and Process developed according to ICH standards

 

www.ribobio.com



 

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