Sylentis is a leading CDMO based in the European Union, dedicated to the development and manufacturing of therapeutic oligonucleotides. With nearly two decades of experience and a cutting-edge 10,000 m² facility near Madrid (Spain), we provide end-to-end support across the oligonucleotide lifecycle. Our flexible GMP manufacturing capabilities—from milligram to kilogram scale—are backed by advanced synthesis platforms and a robust, diversified supply chain that ensures reliability and quality.

What sets Sylentis apart is our deep expertise in CMC strategy and hands-on experience with therapeutic oligonucleotides. We go beyond manufacturing to help clients anticipate regulatory challenges and design resilient development plans. Our comprehensive analytical services span early-phase method development to late-phase validation and ICH stability studies, ensuring phase-appropriate, compliant data generation.

Our regulatory team brings direct experience with FDA and EMA submissions, integrating regulatory writing into development and manufacturing processes. This proactive approach streamlines dossier preparation and accelerates timelines for IND, IMPD, and NDA/MAA submissions. Whether collaborating with your regulatory team or providing full-service support, Sylentis is your trusted partner in bringing oligonucleotide therapies to market.

Sylentis CDMO - highlights (EN)

• Sylentis has nearly 20 years of experience in developing therapeutic oligonucleotides. Our state-of-the-art plant in Europe can produce up to 380 kg/year.
• From milligrams to kilograms, we provide full manufacturing support with maximum flexibility to meet customer specifications.
• We offer comprehensive analytical support, including method development, validation, transfer, impurity characterization, and stability studies.
• Leveraging knowledge from our clinical programs (currently in phase 3), we ensure seamless development for our clients and provide ad hoc support in dossier authoring.