The invention of medical Oligonucleotides made medical treatment for genetic disorders revolutionary. On April 12, 2024, S. L. Lovelock's team from the University of Manchester published an article entitled "Modern approaches to therapeutic oligonucleotide manufacturing". The paper elaborates the way to optimize the efficiency of production, consistent products, large scale production to serve the market with new technologies and meet the rigid regulations.
A few oligonucleotide drugs have already been approved by the FDA. The National Medical Products Administration approved Novartis’ novel siRNA injection drug Inclisiran for marketing as a complementary medicine to diet for the treatment of adult primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia on its website on 22 August 2023.
Fig. 1 The therapeutic oligonucleotide landscape. (Obexer, et al., 2024)
This review integrates recent advances in synthetic chemistry, biocatalysis, and analytical technologies, focusing on different technical approaches such as the optimization of Solid-phase Synthesis techniques, innovations in Oligonucleotide Modification chemistry, and the introduction of continuous flow processes to improve yields and purity. At the same time, R&D personnel use advanced analysis tools for real-time monitoring to ensure product quality. A series of data demonstrates that modern manufacturing strategies significantly improve the scalability and cost-effectiveness of Oligonucleotide Production. Continuous flow chemistry in tandem with automation streamlines production cycles and batch reliability. High purity and safety products are achieved using the high resolution mass spectrometry and liquid chromatography. These technologies and procedures create the technical basis for accelerating therapeutic oligonucleotide clinical delivery, and enable personalized medicine by decreasing the price tag and increasing access.
The manufacturing processes presented here give the pharma industry an actual solution to create effective and scalable manufacturing process to adapt to the therapeutic oligonucleotide market’s expansion.
Cat# | Product Name | Purity | Inquiry |
X22-09-ZQ071 | Adenosine 5'-triphosphate (ATP) sodium salt solution, 100 mM | >98% | Inquiry |
X22-09-ZQ072 | Guanosine 5′-triphosphate (GTP) sodium salt solution, 100 mM | >98% | Inquiry |
X22-09-ZQ073 | Cytidine-5'-triphosphate (CTP) sodium salt solution, 100 mM | >98% | Inquiry |
X22-09-ZQ074 | Uridine 5'-triphosphate (UTP) sodium salt solution, 100 mM | >98% | Inquiry |
X22-09-ZQ075 | Adenosine 5'-triphosphate (ATP) tris solution, 100 mM | >98% | Inquiry |
X22-09-ZQ076 | Guanosine 5′-triphosphate (GTP) tris solution, 100 mM | >98% | Inquiry |
X22-09-ZQ077 | Cytidine-5'-triphosphate (CTP) tris solution, 100 mM | >98% | Inquiry |
X22-09-ZQ078 | Uridine 5'-triphosphate (UTP) tris solution, 100 mM | >98% | Inquiry |
X22-09-ZQ079 | 5-Me-CTP solution, 100 mM | >98% | Inquiry |
X22-09-ZQ080 | 5-O-Me-UTP solution, 100 mM | >98% | Inquiry |
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