Delivering macromolecules, like oligonucleotides or monoclonal antibodies, in a sustained release manner comes with several hurdles. ProMed has experience developing sustained release formulations to deliver macromolecules to address key challenges including:
Instability: Macromolecules are often delicate and prone to degradation during formulation or within the body. Finding the right balance of protecting them while allowing for release is crucial.
Burst release: An initial burst of the macromolecule can occur right after administration, defeating the purpose of sustained release. Formulating the delivery system to achieve a controlled release profile is a challenge.
Compatibility: The size and properties of the macromolecule need to be compatible with the chosen delivery system. Additionally, the delivery system itself should be biocompatible and not cause any harm in the body
Manufacturing complexities: Sterile or aseptic manufacturing techniques are typically required as conventional terminal sterilization methods