Protein Based Pharmaceuticals

Proteins are complex bio-molecules responsible for a great number of functions in the human body.  Each protein has a specific task it must accomplish – signaling, regulation, transcription or structure, for example – and researchers have discovered that many diseases are related to defects in proteins.  For this reason, pharmaceutical companies have greatly expanded their research and development efforts on protein based pharmaceuticals in recent years.

Unfortunately a protein’s complex nature also makes it very fragile, a fact that requires it to be maintained in precise conditions to ensure its activity.  While freezing proteins in solution has been used, it is a costly proposition considering the many financial and logistical drawbacks of cold-chain storage.  A better alternative is to convert pharmaceuticals into a dry powder, where room temperature shelf stability can be maintained for years.  Traditional dry powder manufacturing methodologies, including lyophilization and spray drying, can be damaging to the proteins they are trying to protect.  ASFD is a gentler process and allows for greater flexibility during formulation.