TECHNOLOGY
Oligonucleotide manufacturing

We accompany you from the beginning in the laboratory to the market launch

Sylentis has the expertise to carry out the manufacture of synthetic oligonucleotides throughout the product life cycle.

Sylentis has been certified under GMP for Manufacturing Operations of investigational medicinal products by the Spanish Agency for Medicines and Health Products (AEMPS).

Sylentis has more than 10 years experience in the GMP analysis of therapeutic oligonucleotides. Since 2019, it has incorporated the GMP production of these products into its activities.

 

Phases and Services

Non-clinical / Analytical development

Thanks to the experience of more than 15 years of our specialized oligonucleotide teams, we can offer customized solutions both in manufacturing in scales from 3 mg to 30 g for each synthesis, and in analysis using analytical methods and techniques appropriate for each stage of development. At Sylentis we always keep in mind the importance of reproducibility and scalability.

Method development and validation

Our commitment to managing the challenges involved in oligonucleotide synthesis and analysis is reflected in every step of the process. That is why we cover regulatory needs during development, or method transfer and validation through to ICH stability studies.

We develop customized methods and method transfers from other laboratories according to current GMP.

Scaling and stability studies

For Sylentis, confidence in accuracy and strict GMP compliance is paramount. Backed by our experience, we have the means to support batch production at various scales.