Parenteral biologics delivery: recent progresses, key challenges and perspectives

摘要

This review presents recent progresses in the field of parenteral protein delivery, with emphasis on the most successful technologies. Two strategies have been explored and developed to improve parenteral biologics delivery, providing long-acting protein formulations. One is based on post-translational modification/conjugation and, more recently, genetic fusion, to generate long-acting proteins with controlled molecular features and lower immunogenicity. A more recent strategy is conversely based on depot sustained-release formulations of unmodified proteins with specific functionality, such as release rate and pharmacokinetic profile. These new products bring significant improvements in convenience of administration, tolerability of treatment and compliance by reduction of injection frequency, as well as optimisation of safety/efficacy balance by modifying pharmacokinetics and achieving prolonged therapeutic concentrations. Advantages and limitations of both strategies and technologies are also discussed.