Custom GMP Pharma-Grade DNA & RNA Oligonucleotide Synthesis Manufacturing

Accelerate your clinical trials with high-purity, cGMP DNA and RNA oligonucleotide synthesis. We provide pharma-grade oligos with full regulatory documentation, scalable from mg to kg. Explore our custom synthesis services today.

At Zeptide Pharma, we ensure your path to market is seamless by getting small molecule manufacturing right the first time. By integrating end-to-end pharmaceutical development solutions with the deep scientific expertise required for complex formulations, we transform challenges into clinical success. With over 25 years of industry leadership, we provide the stability and innovation your molecule deserves.

Bridge the gap between discovery and the clinic with our GMP-grade DNA and RNA oligonucleotide synthesis services. Zeptide Pharma provides high-purity, therapeutic-grade genetic material that meets the rigorous standards of the pharmaceutical and biotech industries.

Whether you are developing mRNA vaccines, antisense oligonucleotides (ASOs), or siRNA therapeutics, our state-of-the-art cGMP manufacturing facility ensures your molecules are synthesized with unparalleled precision and consistency.

Our Core Synthesis Capabilities

Custom DNA Oligonucleotides: High-fidelity synthesis for gene assembly, diagnostic probes, and therapeutic applications.
GMP RNA Synthesis: Specialized production of siRNA, sgRNA for CRISPR, and Aptamers, featuring extensive modification options.
Modified Oligos: Expert incorporation of phosphorothioate (PS) linkages, 2’-OMe, 2’-F, and LNA to enhance stability and potency.
Scalable Manufacturing: Seamless transition from R&D pilot batches (mg) to large-scale pharma-grade manufacturing (kg).

Why Choose Our Pharma-Grade Oligonucleotides?

To rank as a leader in nucleic acid therapeutics, we prioritize quality and compliance at every step:

ISO-Certified & cGMP Compliant: Our processes adhere to strict global regulatory guidelines to ensure safety and efficacy for human clinical trials.
Advanced Purification: We use high-performance HPLC and Ultrafiltration to ensure maximum purity and the removal of truncated sequences.
Comprehensive Analytical Testing: Every batch undergoes rigorous Mass Spectrometry (MS), Capillary Electrophoresis (CE), and endotoxin testing.
Full Documentation Support: We provide complete Chemistry, Manufacturing, and Controls (CMC) documentation to streamline your IND (Investigatory New Drug) applications.

Applications for Our GMP Oligos

Gene Therapy: Reliable components for viral vector production and gene editing tools.
Molecular Diagnostics: High-purity primers and probes for IVD
RNA Interference (RNAi): Stable, high-potency siRNA for gene silencing research.
Vaccine Development: High-quality templates for mRNA vaccine production.

Our Advantage

In the competitive landscape of biopharmaceutical manufacturing, timing is everything. Our streamlined workflow ensures rapid turnaround times without compromising on quality. When you search for a GMP oligonucleotide supplier, you need a partner that understands the nuances of scale-up and regulatory submission.

Life Science Capabilities

Our facility offers elite capabilities across drug product development, large-scale manufacturing, and sterile finish services. As industry leaders in handling complex oral solid dosage (OSD) forms, we provide a sophisticated infrastructure that is fully cGMP certified. From pilot studies to large-scale commercial manufacturing, our operations serve a global network spanning over 100 countries.

State-of-the-Art US-Based cGMP Facility

Zeptide Pharma operates a premier, state-of-the-art cGMP manufacturing facility in the United States. Architecturally and operationally designed to exceed the highest international standards, our site is a hub for:

Aseptic Fill/Finish & Sterile Processing
Pharmaceutical Packaging & Clinical Labeling
Rigorous Analytical Testing & Stability Studies

World Health Organization Global Reach & Regulatory Excellence

We facilitate the cGMP manufacture and global supply of finished drug products to premier markets, including North America, Europe, Asia, and the Middle East. Our commitment to compliance is validated by a flawless track record of inspections from the world’s most stringent global regulatory authorities, including: