Author Archives: Ashleigh Wake

Development of a Strategic Quality Control Program for mRNA Vaccines

Messenger RNA (mRNA) therapeutics have the potential to revolutionize several areas of medicine, including the prophylaxis of infectious disease. That potential is driven not only by therapeutic advantages of this modality, but also the relative ease in which a product can be produced and scaled — thus reducing cost and importantly, time to market. mRNA therapeutics have an enhanced safety profile driven in part from their mode of action not requiring integration into the host-cell genome. mRNA vaccines are a…

Analytical Challenges: Characterization of Oligonucleotide Therapeutics

Recent approvals of oligonucleotide therapeutics are a clear signal for optimism for this product class. This is supported by the strength of the current pipeline which has over 180 active oligonucleotide clinical programs in various phases of development. Improvements in analytical technology and know-how have played a key role in enabling suitable characterization and quality control strategies to overcome the difficulties associated with testing these complex molecules. Despite the lack of dedicated regulatory guidelines related to characterization or quality control,…