Explore our high-purity commercial Active Pharmaceutical Ingredients manufactured under strict cGMP protocols for global clinical and regulatory standards.
Driving the Paradigm Shift in Molecular Therapeutics: From Small Molecules and Antibodies to Targeted Genetic Medicines
Oligonucleotide Active Pharmaceutical Ingredients (APIs) represent a powerful class of therapeutic agents designed to target genetic machinery directly at the transcriptomic level. By utilizing short synthetic strands of nucleic acids—such as antisense oligonucleotides (ASOs), small interfering RNAs (siRNAs), microRNAs (miRNAs), and aptamers—oligonucleotide APIs selectively bind to precursor mRNA or mature mRNA transcripts via complementary base pairing. This biological interaction can alter gene expression through RNase H-mediated cleavage, RNA interference (RNAi), splice modulation, or direct translational inhibition.
As a leading Oligonucleotide APIs Manufacturer & Company, Gentolex is at the forefront of scaling complex chemical modifications. Modern clinical candidates rely heavily on chemical modifications—including 2'-O-methyl (2'-OMe), 2'-fluoro (2'-F), Locked Nucleic Acids (LNA), and phosphorothioate (PS) backbone modifications—to overcome systemic enzymatic degradation by endo- and exonucleases, minimize off-target immune activation via Toll-like receptors (TLRs), and enhance pharmacokinetic profiles.
Robust engineering, automated solid-phase platforms, and advanced chromatographic separation technologies ensuring high-yield output
Automated Solid-Phase Synthesis (SPOS) using high-purity nucleoside phosphoramidites under inert nitrogen protection, achieving >99% stepwise coupling yield.
Controlled chemical oxidation to generate native phosphodiester linkages or efficient sulfurization using EDITH/PADS reagents to form phosphorothioates.
Basic cleavage from solid support (CPG/Polystyrene resin) followed by thermal deprotection of exocyclic amine protecting groups (Benzoyl, Isobutyryl, Acyl).
Ion-exchange (IEX) and Reverse-Phase (RP-HPLC) chromatography, followed by ultrafiltration desalter and commercial cGMP lyophilization.
Our cGMP testing facilities leverage high-resolution ESI-Q-TOF mass spectrometry and Ion-Pair Reversed-Phase HPLC (IP-RP-HPLC) for rigorous characterization of truncated (n-1, n-2) impurities, depurinated species, and heavy metal residuals, verifying molecular weight precision to within < 1 Da.
Full technical documentation including Drug Master Files (DMF) for US FDA, CEP filings for EMA, NMPA dossier preparation, validation of analytical protocols according to ICH Q6B guidelines, and stress stability studies under controlled temperature/humidity conditions.
Operating under ISO 13485 and ICH Q7 standard compliance. Complete raw material traceability for modified nucleosides, linkers, solvents (acetonitrile, DCM, pyridine), and coupling reagents, backed by automated batch execution records.
The global bio-pharmaceutical sector requires highly integrated, scalable, and resilient supply chains to bring novel RNA therapeutics to market efficiently. China has established itself as an indispensable powerhouse in the oligonucleotide CDMO ecosystems, providing unique structural advantages for global innovator companies:
Direct domestic access to precursor nucleosides, specialized 2'-modifications (2'-F, 2'-OMe, 2'-MOE), phosphorothioate reagents, and solid supports dramatically reduces lead times and material procurement costs.
With substantial operational efficiencies, advanced automated synthesizers, and massive purification column capacities, China-based facilities significantly lower capital expenditure (CapEx) per gram of API synthesized.
Houses vast teams of skilled analytical chemists, process development scientists, and quality assurance professionals experienced in fast-tracking projects from discovery scale to multi-kilogram cGMP commercial batches.
Global pharmaceutical procurement directors face multi-faceted challenges when procuring commercial RNA active substances: maintaining batch consistency, mitigating raw material bottlenecks, avoiding IP leakage, and securing rapid turnaround times.
Expanding Therapeutic Horizons from Ultra-Rare Genetic Disorders to Mass-Market Chronic Conditions
RNAi therapeutics such as Inclisiran (targeting PCSK9 for hypercholesterolemia) and Zilebesiran (targeting angiotensinogen for refractory hypertension) demonstrate the viability of long-acting oligonucleotide APIs for broad population chronic disease management with twice-yearly dosing regimens.
Targeted therapies like Givosiran (Acute Hepatic Porphyria), Fitusiran (Hemophilia A/B), and Donidalorsen (Hereditary Angioedema) prove that custom GalNAc-siRNA conjugates can offer transformative therapeutic benefits to underserved rare disease patient cohorts globally.
The industry is undergoing a massive shift towards extrahepatic delivery. Through chemical conjugation with lipophilic moieties (e.g., C16, palmitic acid), antibodies, or specialized peptides, emerging oligonucleotide APIs target CNS (ALS, Huntington's), ocular, and pulmonary tissues.
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.
An overall factory construction area of 250,000 square meters under international standard to offer flexible, scalable and cost-effective solutions.
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.
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.
Complete technology transfer, FDF licensing support, setup consultation for analytical laboratories, and batch process validation.
Stay informed with the latest scientific publications, peptide API synthesis advancements, and regulatory updates from Gentolex chemists.
Selank Acetate API is a synthetic heptapeptide active pharmaceutical ingredient composed of the amino acid sequence Thr-Lys-Pro-Arg-Pro-Gly-Pro. Originally developed through neuropharmacological research, Selank acts as a neuroactive therapeutic agent...
View Details
As a professional Thymosin Beta-4 API manufacturer and supplier, we provide high-quality Thymosin Beta-4 peptide API solutions for biotechnology companies, pharmaceutical research organizations, and commercial partners worldwide...
View Details
BPC-157 API is a synthetic pentadecapeptide that has gained increasing attention in peptide research due to its potential biological activities related to tissue repair, gastrointestinal protection, and inflammatory regulation...
View Details
With continuous development in neuroscience and peptide technology, neuroactive peptides have become a major focus. Semax, derived from an ACTH fragment, features unique target binding for cognitive and restorative applications...
View Details
SS-31 API, also known as Elamipretide, MTP-131, Bendavia, and SS31, is a synthetic mitochondria-targeting tetrapeptide designed to bind cardiolipin in the inner mitochondrial membrane to stabilize bioenergetics...
View DetailsDetailed technical answers for global procurement teams, CMC leads, and oligonucleotide buyers.
Explore our additional portfolio of high-purity therapeutic APIs, peptide sequences, and specialty reagents.
