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European Biopharmaceutical Review

Complex Characters

Oligonucleotides are biopolymers consisting of modified ribonucleotide or deoxynucleotide monomer units. Since they play such a critical role at the human cellular level, they are being developed by several biopharmaceutical organisations as potential therapies and vaccines and are considered to be their own unique modality, distinct from traditional small molecule drugs and biologics.

The FDA has approved a number of these biopolymers, including fomivirsen, pegaptanib and mipomersen, primarily antisense oligonucleotides (ASOs), with several more on the way. In Europe, the Committee for Medicinal Products for Human Use, a division of the EMA, has recently recommended nusinersen for approval. n 100 oligonucleotide drugs progressing through the development pipeline, designed to target diseases and rare genetic disorders, including Huntington’s disease, asthma and certain types of cancer, as well as vaccines for the Ebola, Zika and influenza viruses.

Brief Background

Messenger RNA (mRNA) is a type of oligonucleotide that is critical to the translation of genetic sequence information of DNA into the specific amino acid array of proteins manufactured in the ribosomes of a cell’s cytoplasm. In eukaryote human cells, mRNA consists of several distinct regions. This naturally occurring sequence is known as the sense sequence.

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Jon S Kauffman, PhD, is Senior Director of Biopharmaceutical Services and Method Development and Validation at Eurofins Lancaster Laboratories. With more than 25 years of analytical testing experience, he oversees departments responsible for developing and validating methods and performing analysis of clinical and commercial samples for stability and release purposes. Jon earned a doctorate in chemistry from the University of Delaware, US.
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