Extending oligonucleotide research and development through long-term alliances
Syngene provides a comprehensive set of oligonucleotide synthesis services ranging from development to the manufacture of chemically synthesized oligonucleotides for customers across the world. We synthesize various scales of high-quality modified and non-modified custom oligonucleotides (DNA/RNA), single and double-stranded small interfering ribonucleic acid (siRNA), modified and non-modified microRNA (miRNA), and antisense oligonucleotides with rapid turnaround time.
Our highly qualified and experienced researchers use advanced technology platforms to provide process development, manufacturing, and analytical support for various long-term programs set-up in partnership with several global clients.
Syngene’s oligonucleotide facility started with a process development lab in 2014 and extended to a manufacturing facility in 2017 that is compliant with current good manufacturing practice (cGMP) regulations. Our independent, yet integrated quality management system, has been approved by several national and international regulatory agencies, including the US Food and Drug Administration (FDA).
Syngene’s scale of operation ranges from 0.25 to 6 millimoles in development, and from 4 to 45 millimoles at GMP conditions to support research and development (R&D), process development, and preclinical studies.
Syngene’s non-GMP development facility is equipped with world-class ÄKTA Oligopilot 100, a fully automated synthesizer of regular and modified oligonucleotides that caters to a variety of R&D applications. Modified oligonucleotides include DNA/RNA, siRNA, antisense, aptamer, miRNA, and oligopeptide conjugates. Our synthesis services are scalable from 250 micromoles to 6 millimoles (1 to 25 grams) with sequence lengths of 10 to 30-mer. Besides solid-phase synthesis, we also develop and scale up enzymatic reactions to synthesize long RNA polymers, such as poly I and poly C.
Syngene’s over 1500 square feet state-of-the-art cGMP manufacturing facility is capable of handling various classes of oligonucleotides. Our facility is equipped with General Electric’s ÄKTA Oligopilot 400 that can manufacture GMP-grade chemically synthesized regular and modified oligonucleotides for toxicology studies and clinical trials. Our synthesis services scale from 4 to 45 millimoles (6 to 135 grams) with sequence lengths of 10 to 30-mer.
Syngene provides comprehensive in-house analytical support for developed or manufactured oligonucleotides. Our experts work with clients to transfer, develop, qualify, and validate analytical methods. We perform comprehensive in-process and lot release procedures for method development and undertake qualification of methods for toxicology or early-phase clinical studies. Our scientists also deliver accurate product characterization reports using various analytical methods.