What is SYOLIGO?

SYOLIGO is an R&D and First Industrial Deployment project carried out by Sylentis for the development and sustainable manufacturing of RNA-based therapies for rare diseases in Spain and Europe.

Time frame – With a duration from 2023 to 2030, SYOLIGO establishes the technological base and facilities necessary to make Sylentis a leading EU biopharmaceutical industry in the development and manufacture of RNA nucleic acid-based products.

Sylentis, with the SYOLIGO project, seeks to become a European benchmark in the sustainable production of oligonucleotides, to promote new therapeutic approaches with RNA oligonucleotides aimed at rare diseases.

SYOLIGO will strengthen the technology base and provide the essential facilities to support the sustainable growth of Sylentis as a leading pharmaceutical company in the EU, specializing in the development and production of RNA-based products.

Research and development (R&D)

  • Develop RNA-based therapies for the most efficient targeted treatment of rare diseases.
  • Actively collaborate with IPCEI partners.

First industrial deployment (FID)

  • Start-up of a new sustainable oligonucleotide production plant in Spain.
  • Reduction of the PMI sustainability parameter of the oligonucleotide manufacturing process.
  • Introduction of innovative oligonucleotide production processes.

Time frame – With a duration from 2023 to 2030, SYOLIGO establishes the technological foundations and facilities necessary to make Sylentis a leading EU biopharmaceutical industry in the development and manufacture of RNA nucleic acid-based products.

Sylentis, with the SYOLIGOproject, seeks to become a European benchmark in the sustainable production of oligonucleotides, to promote new therapeutic approaches with RNA oligonucleotides aimed at rare diseases and to become a European benchmark in the sustainable production of oligonucleotides.

SYOLIGO will create the technology base and enable the facilities necessary to sustainably grow Sylentis as a leading pharmaceutical industry in the EU for the development and manufacture of RNA nucleic acid-based products.

Research and development (R&D)

  • Develop RNA-based therapies for the most efficient targeted treatment of rare diseases.
  • Actively collaborate with IPCEI partners.

First industrial deployment (FID)

  • Start-up of a new sustainable oligonucleotide production plant in Spain.
  • Reduction of the PMI sustainability parameter of the oligonucleotide manufacturing process.
  • Introduction of innovative oligonucleotide production processes.

RNA-based drugs

Oligonucleotide-based therapies have been a revolution in medicine because of their ability to precisely control the production of a disease-associated protein, correct a mutation, and target a variety of therapeutic pathways and targets previously without treatment options.

The high success rate of regulatory authorities in approving these types of drugs demonstrates this rapid expansion (FDA and EMA). RNA-based therapies have recently produced FDA and EMA-approved treatments for extremely rare metabolic and degenerative disorders that significantly address unmet medical needs and have high therapeutic value (annual treatment cost between 400,000 and 800,000 euros). In fact, progress has been made to the point that, over the past five years, drugs have been authorized every year, representing 7% of FDA-approved drugs in 2023.

* Infographic extracted from OLIGOFASTX’s Discovering Therapeutic Oligonucleotides guide.

access the guide download

The commitment made by both European and North American regulatory agencies to RNA oligonucleotide therapies for the treatment of rare diseases and legislation articulated as Regulation 141/2000 of the Orphan Drug Act in the EU, has resulted in hundreds of new orphan drugs, mostly for rare diseases. Oligonucleotide-based therapies are one of the best tools for the development of therapies to meet the needs of very complex rare diseases, thanks to their versatility and specificity, and a path of no return has been opened.

There are currently 21 oligonucleotide-based drugs approved for many different diseases and many more under investigation. Sylentis’ mission with SYOLIGO provides the impetus for the emergence of new RNA therapies for patients with rare diseases, not only because it is developing its own molecules, but also because it is providing itself with a capacity for CDMO of oligonucleotides in a sustainable way that is pioneering in Spain.

RNA-based drugs

Oligonucleotide-based therapies have been a revolution in medicine because of their ability to precisely control the production of a disease-associated protein, correct a mutation, and target a variety of therapeutic pathways and targets previously without treatment options.

The high success rate of regulatory authorities in approving these types of drugs demonstrates this rapid expansion (FDA and EMA). RNA-based therapies have recently produced FDA and EMA-approved treatments for extremely rare metabolic and degenerative disorders that significantly address unmet medical needs and have high therapeutic value (annual treatment cost between 400,000 and 800,000 euros). In fact, progress has been made to the point that, over the past five years, drugs have been authorized every year, representing 7% of FDA-approved drugs in 2023.

* Infographic extracted from OLIGOFASTX’s Discovering Therapeutic Oligonucleotides guide.

access the guide download

The commitment made by both European and North American regulatory agencies to RNA oligonucleotide therapies for the treatment of rare diseases and legislation articulated as Regulation 141/2000 of the Orphan Drug Act in the EU, has resulted in hundreds of new orphan drugs, mostly for rare diseases. Oligonucleotide-based therapies are one of the best tools for the development of therapies to meet the needs of very complex rare diseases, thanks to their versatility and specificity, and a path of no return has been opened.

There are currently 21 oligonucleotide-based drugs approved for many different diseases and many more under investigation. Sylentis’ mission with SYOLIGO provides the impetus for the emergence of new RNA therapies for patients with rare diseases, not only because it is developing its own molecules, but also because it is providing itself with a capacity for CDMO of oligonucleotides in a sustainable way that is pioneering in Spain.

Sustainable production of therapeutic oligonucleotides

Current oligonucleotide synthesis processes present significant challenges in terms of sustainability. Conventional chemical synthesis, which uses phosphoramidite methods, generates high volumes of chemical waste, such as solvents and hazardous reagents, which require specialized management. In addition, traditional methods consume large amounts of energy. This model is not compatible with a continuous growth in demand without a severe environmental impact, so it is essential to develop cleaner and more efficient processes.

On the scientific side, a promising solution lies in the optimization of synthesis processes, including the design of reactions that maximize yield and minimize by-products. For example, the use of less toxic reagents and green solvents could significantly reduce the environmental impact. In parallel, enzymatic approaches for oligonucleotide synthesis are being explored, which could offer more sustainable alternatives to relying on specific biocatalytic systems. These techniques, although still in the developmental stages, have the potential to transform the industry by being inherently less environmentally aggressive. Another key aspect is the integration of circular economy principles in the production of oligonucleotides.

Sustainable production of therapeutic oligonucleotides

Current oligonucleotide synthesis processes present significant challenges in terms of sustainability. Conventional chemical synthesis, which uses phosphoramidite methods, generates high volumes of chemical waste, such as solvents and hazardous reagents, which require specialized management. In addition, traditional methods consume large amounts of energy. This model is not compatible with a continuous growth in demand without a severe environmental impact, so it is essential to develop cleaner and more efficient processes.

On the scientific side, a promising solution lies in the optimization of synthesis processes, including the design of reactions that maximize yield and minimize by-products. For example, the use of less toxic reagents and green solvents could significantly reduce the environmental impact. In parallel, enzymatic approaches for oligonucleotide synthesis are being explored, which could offer more sustainable alternatives to relying on specific biocatalytic systems. These techniques, although still in the developmental stages, have the potential to transform the industry by being inherently less environmentally aggressive. Another key aspect is the integration of circular economy principles in the production of oligonucleotides.