Protein expression therapy using nucleic acid macromolecules (NAMs) as a
new paradigm in medicine has recently gained immense therapeutic
potential. With the advancement of nonviral delivery it has been possible
to target NAMs against cancer, immunodeficiency and infectious diseases.
Owing to the complex and fragile structure of NAMs, however,
development of a suitable, stable formulation for a reasonable product
shelf-life and efficacious delivery is indeed challenging to achieve. This
review provides a synopsis of challenges in the formulation and stability of
DNA/m-RNA based medicines and probable mitigation strategies
including a brief summary of delivery options to the target cells. Nucleic
acid based drugs at various stages of ongoing clinical trials are compiled.