By Chris Rombach, Vice President of Sales and Marketing, Asahi Kasei Bioprocess America
The rapidly growing market for Oligonucleotide manufacturing represents a lucrative opportunity for investors and pharmaceutical companies that wish to produce novel pharmaceutical products and therapies. So far, synthetic oligonucleotides have been studied and used extensively in the creation of new pharmaceuticals and at least ten oligonucleotide drugs have already been approved by the Food and Drug Administration (FDA).
While Pfizer’s drug Macugen is the best-known oligonucleotide drug on the market today, there are about 250 programs under development for new drug approvals. Industry insiders, such as Neil McKenna Ph.D., predict that roughly 10% of new drug approvals by the FDA will be oligonucleotide-based. The projection further emphasizes this industry niche’s potential for exponential developments.
Given the excitement from investors and big pharma around oligonucleotide drugs, industry professionals scrutinize how oligonucleotide manufacturing can be scaled, including the price of raw materials, cost-effectiveness, reproducibility, and quality assurance concerns. With the abundance of opportunities this class of drug represents, let’s explore what exactly oligonucleotides are and the five biggest trends in oligonucleotide manufacturing in 2022.