Since the approval of the first antisense therapy in 1998, oligonucleotides have been in light for their capabilities as therapeutic agents. Oligonucleotides are short synthetic nucleotide chains with immense potential in the diagnosis and treatment of a myriad of disease indications. In addition to therapeutics, these complex molecules act as a significant resource in various research applications. The onset of the COVID-19 pandemic has contributed greatly to the increasing demand of oligonucleotide-based products, consequently, proposing lucrative opportunities for custom / contract service providers engaged in this domain.
It is worth highlighting that oligonucleotide synthesis is a complex and labor-intensive process. It involves chemical synthesis of nucleic acid fragments with a defined chemical structure and varying length and sequence. However, with the introduction of advanced technologies, involving the use of phosphoramidite monomers and tetrazole catalysis, has made this process more convenient and efficient. The overall manufacturing of oligonucleotides involves the following steps.
Owing to the incessant demand for oligonucleotide-based products, several small to mid-sized companies and certain pharma giants, have begun outsourcing their manufacturing operations to contract service providers. Outsourcing offers several benefits to the developers including cost saving opportunities, increased operational efficiencies, expedited time-to-market, access to advanced capabilities and technologies, validated quality control setup, flexibility, risk sharing and, in several cases, regulatory support. Despite the advantages of outsourcing complex manufacturing operations offered, a number of parameters add on to the complexity of selecting an appropriate service provider. Some of the commonly considered parameters include
The selection of a wrong / improper service provider partner can prove to be disastrous in the long run, wherein issues, such as delays and cost overruns, crop up. Therefore, it is of utmost importance to access the expertise and capabilities of potential service providers.
It is worth highlighting that a wide variety of oligonucleotide-based interventions have been developed in the past few years. Further, it is believed that, given their high specificity and favorable biological tolerance profiles, these molecules are likely to evolve into one of the key therapeutic classes in the near future.
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