Sylentis

Sylentis

Oligonucleotide manufacturer

About the plant

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.

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Certifications

• EMA (EU GMP)

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Activity

• OLIGONUCLEOTIDES, ASOs (Antisense oligonucleotides), siRNA, miRNA, Aptamers, PMOs manufacturing

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Features

• Uses: Investigational, Preclinical, Phase I, Phase II, Phase III, Human
• Toxicity (OEB classification): 3 (PDE = 100 - 1,000 µg/day)
• DEA: N/A
• BSL:
• Therapeutic areas: N/A
• Markets: FDA (USA), EMA (EU)

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Batch Size / Reactor

• Small, Medium, Large

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Services

• Regulatory services, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, R&D, QbD (Quality by Design), Process development, Process optimization, Process validation, Lyophilization cycle development, Stability studies design, Stability studies execution, ICH Stability studies, Comparability studies, Tech transfer, Pilot plant, Lyophilization, Research batches, Engineering batches, Scale-up, Pilot batches, Registration batches, Batch records, Clean room rental, Analytical methods development, Analytical methods validation, Release testing of raw materials, Release testing of product, Analytical methods transfer, Batch certification / release, GMP documentation, CMC regulatory support, IND (Investigational New Drug aplication) filing support, IMPD (Investigational Medicinal Product Dossier) submission support, NDA (New Drug Application) submission support, ANDA (Abbreviated New Drug Application) submission support, DMF (Drug Master File) preparation and submission

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