Oligonucleotide APIs Factory & Products Serving Sweden

Empowering Nordic Life Sciences with Advanced cGMP Oligonucleotide & Peptide APIs | High-Purity RNA Synthesis, GalNAc Conjugation, and Robust Sino-Swedish Supply Chain Solutions

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250,000 m²
cGMP Production Base
>99.0%
HPLC Oligo Purity
10+
Global Export Hubs
100%
EMA & Läkemedelsverket Ready
Flagship API Portfolio

Featured Therapeutic Oligonucleotides & Peptides for Swedish Biopharma

Direct factory supply of high-purity clinical and commercial grade Active Pharmaceutical Ingredients (APIs) supporting research institutions and pharmaceutical leaders across Stockholm, Gothenburg, and Medicon Valley.

Sweden’s Evolving Biopharma Ecosystem & Oligonucleotide API Demand

Sweden stands as one of Europe’s premier hubs for life sciences and biopharmaceutical innovation. With prominent research nodes like the Karolinska Institutet in Stockholm, the AstraZeneca BioVentureHub in Gothenburg, and the thriving cross-border Medicon Valley region in Skåne, the Swedish healthcare cluster is driving pioneering work in gene therapy, messenger RNA (mRNA), small interfering RNA (siRNA), and antisense oligonucleotides (ASOs).

As targeted RNA therapies move rapidly from preclinical pipelines to late-stage commercialization, local research teams and contract manufacturing entities require reliable, ultra-pure Active Pharmaceutical Ingredients (APIs). The demand for modified phosphoramidites, GalNAc-conjugated oligonucleotides, and solid-phase synthesis reagents is accelerating across Scandinavia. To meet these stringent requirements, Gentolex provides custom synthesis and large-scale manufacturing of oligonucleotide APIs backed by rigorous compliance frameworks.

Key Strategic Advantages for Swedish Procurement

  • EU cGMP Compliance: Facilities aligned with European Medicines Agency (EMA) and Swedish Medical Products Agency (Läkemedelsverket) standards.
  • Scalable Solid-Phase & Liquid-Phase Technology: Seamless scale-up from milligram research batches to multi-kilogram commercial production.
  • GalNAc & Lipid Conjugation Expertise: Enhancing tissue targeting and cellular uptake for liver-directed RNA therapeutics.
  • Green Chemistry & Environmental Controls: Closed-loop solvent recycling and low-impact synthesis matching Sweden’s strict sustainability goals.
  • Dedicated Cold-Chain Air Freight: Guaranteed direct shipping routes to Stockholm Arlanda (ARN) and Gothenburg Landvetter (GOT) airports with full temperature tracking.

Comprehensive Oligonucleotide & Peptide API Services

Our main services focus on supplying peptides APIs and Custom Peptides, FDF license out, Technical Support & Consultation, Product Line and Lab Setup, Sourcing & Supply Chain Solutions.

Chemicals Products

An overall factory construction area of 250,000 square meters under international standard to offer flexible, scalable and cost-effective solutions for specialty chemicals and nucleotide precursors.

Pharmaceutical Ingredients

Gentolex offers an extensive range of APIs and intermediates for development study and commercial application with cGMP standard from long-term collaborations. Documents and Certificates are supported to customers worldwide.

Development & Synthesis

Advanced oligonucleotide chemical modifications including phosphorothioate (PS) backbone transformation, 2'-O-methyl (2'-OMe), 2'-fluoro (2'-F), and locked nucleic acid (LNA) chemistry tailored for targeted drug development.

Procurement Service

For those clients who prefer to avoid the complexity of dealing with multiple points of contact, we provide extra customized procurement services with the most superior and comprehensive supply chain sources.

Technical Whitepaper: Oligonucleotide API Synthesis & Quality Architecture

Therapeutic oligonucleotides represent a distinct class of biopharmaceuticals bridging small molecules and biologics. Ensuring high full-length sequence integrity (n-mer content) while strictly limiting truncated short-mer impurities (n-1, n-2) requires state-of-the-art chemical synthesis technology and specialized downstream purification systems.

1. Automated Solid-Phase Synthesis

Utilizing high-capacity multi-column automated synthesizers, our factory carries out precise phosphoramidite chemistry cycle by cycle: Detritylation, Coupling, Capping, and Oxidation/Sulfurization. This methodology yields high coupling efficiencies (>99.5% per step), crucial for long-chain oligos up to 30+ nucleotides.

2. Advanced Purification & Desalting

Post-cleavage and deprotection, raw oligonucleotide crude solutions undergo Ion-Exchange Chromatography (IEX) and Reverse-Phase High-Performance Liquid Chromatography (RP-HPLC) purification. Ultrafiltration and nanofiltration steps remove residual organic solvents and inorganic salts, yielding APIs with purity exceeding 98.5%.

3. Analytical Characterization

Every batch destined for Sweden is verified using LC-MS/MS (ESI-TOF) for exact mass identity, IP-RP-HPLC for purity profiling, ICP-MS for heavy metal impurities, and LAL assay for ultra-low endotoxin testing (<0.05 EU/mg), fully compliant with Ph. Eur. and USP guidelines.

Step 1: Monomer Quality Control

Ultra-pure phosphoramidite raw materials verified by 31P-NMR and HPLC prior to reaction.

Step 2: Automated Assembly

Controlled synthesis under inert gas atmosphere preventing moisture contamination.

Step 3: Downstream Refinement

Prep-HPLC fraction collection followed by lyophilization in Class 100 cleanrooms.

Step 4: EU Release & Batch Dossier

Full Certificate of Analysis (CoA), EDMF/ASMF release paperwork ready for Swedish import clearance.

Global Expertise

About Gentolex

Gentolex’s goal is to create opportunities connecting the world with better services and guaranteed products. Up to date, Gentolex Group has been serving customers from more than 10 countries, specially, representatives are established in Mexico and South Africa. Our main services focus on supplying peptides APIs and Custom Peptides, FDF license out, Technical Support & Consultation, Product Line and Lab Setup, Sourcing & Supply Chain Solutions.

Gentolex Laboratory Sweden Service
Gentolex Manufacturing Facility Sweden

Sino-Nordic Supply Chain Synergy: China Factory Advantage

Balancing high-tech innovation with cost efficiency is a major priority for Swedish drug developers and procurement directors. Gentolex bridges Chinese large-scale manufacturing infrastructure with Nordic quality standards.

Cost-Effective Scale

By leveraging our 250,000 m² centralized cGMP production base, clients in Sweden benefit from up to 40% reduction in raw material acquisition costs compared to Western European CDMOs, without compromising quality.

Regulatory Protection

Comprehensive DMF/ASMF dossier support, EDMF registration assistance, and rapid response to Swedish MPA audit questionnaires guarantee seamless regulatory submissions.

Robust Global Logistics

Established logistics partnerships with temperature-controlled cold-chain carriers (-20°C / -80°C / dry ice) ensure fast delivery to Stockholm, Gothenburg, Uppsala, and Lund within 3–5 business days.

News & Technical Articles

Latest technical updates, peptide research insights, and pharmaceutical product releases from Gentolex.

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Global Certification & Strategic Partner Network

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Frequently Asked Questions (FAQ) for Swedish Buyers

Key regulatory, technical, and procurement answers tailored for Swedish biopharmaceutical teams and supply managers.

What chemical modifications do you support for custom oligonucleotide APIs?
We offer comprehensive chemical modifications including phosphorothioate (PS) backbone conversion, 2'-O-methyl (2'-OMe), 2'-fluoro (2'-F), 2'-O-methoxyethyl (2'-MOE), Locked Nucleic Acids (LNA), as well as GalNAc (N-Acetylgalactosamine) conjugation for targeted liver cell delivery.
How do you ensure compliance with Swedish Medical Products Agency (Läkemedelsverket) standards?
All our production sites operate strictly under cGMP conditions aligned with ICH Q7 and EU Annex 1 guidelines. We provide complete EU Drug Master Files (EDMF/ASMF), stability study data under ICH Q1A(R2) conditions, batch production records, and analytical validation dossiers required for European and Swedish regulatory clearances.
What are the lead times and shipping procedures for orders to Sweden?
Standard catalog peptide and oligo APIs are dispatched within 2–3 business days. Custom synthesis contracts typically require 3 to 6 weeks depending on sequence length and complexity. We utilize validated cold-chain air courier services (Express to ARN or GOT) with real-time temperature telemetry (-20°C / dry ice).
Can Gentolex accommodate small-scale R&D batches alongside commercial kilogram supply?
Yes. Our modular facility handles initial research quantities (grams to tens of grams) under strict GLP/GMP conditions and scales smoothly up to multi-kilogram commercial batches with total batch-to-batch reproducibility.

Ready to Secure Your Oligonucleotide API Supply Chain in Sweden?

Partner with Gentolex for certified cGMP manufacturing, competitive direct-factory pricing, and expert technical support for your RNA and peptide programs.

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