Oligonucleotides have changed the shape of the pharmaceutical industry. They are a class of drugs composed of short strands of RNA or DNA that can be synthetically manipulated to alter the expression of a number of disease-causing proteins. Until recently, the majority of Food and Drug Administration (FDA) approved oligonucleotides on the market have been used for the treatment of rare diseases. However, recent approvals have highlighted their potential in targeting a breadth of more common diseases with larger patient populations, including cardiovascular disease, oncology and metabolic disorders.
It is important to acknowledge that the current oligonucleotide supply chain is unsustainable and faces significant barriers to scaling up, highlighting a critical supply and demand gap which needs to be addressed.
This report highlights three key areas as important considerations for change, and marks the importance of innovation and collaboration in making sustainable improvements to scale the oligonucleotide supply chain.
Sustainability - investing in new facilities with sustainable and scalable manufacturing procedures.
Regulatory infrastructure - Developing a clear regulatory infrastructure for different types of oligonucleotides.
Skills and shortages - Developing a centralised educational hub to meet oligonucleotide workforce demands.