Drug-loaded erythrocytes: on the road toward marketing approval

Abstract

Erythrocyte drug encapsulation is one of the most promising therapeutic alternative approaches for the administration of toxic or rapidly cleared drugs. Drug-loaded erythrocytes can operate through one of the three main mechanisms of action: extension of circulation half-life (bioreactor), slow drug release, or specific organ targeting. Although the clinical development of erythrocyte carriers is confronted with regulatory and development process challenges, industrial development is expanding. The manufacture of this type of product can be either centralized or bedside based, and different procedures are employed for the encapsulation of therapeutic agents. The major challenges for successful industrialization include production scalability, process validation, and quality control of the released therapeutic agents. Advantages and drawbacks of the different manufacturing processes as well as success key points of clinical development are discussed. Several entrapment technologies based on osmotic methods have been industrialized. Companies have already achieved many of the critical clinical stages, thus providing the opportunity in the future to cover a wide range of diseases for which effective therapies are not currently available.

Keywords:

• red blood cell
• encapsulation method
• drug carrier
• industrial development
• clinical use

Disclosure

Vanessa Bourgeaux is an employee of ERYTECH Pharma. Yann Godfrin is the Vice President of ERYTECH Pharma. Bridget E Bax is a member of the Scientific Advisory Board of ERYTECH Pharma. The authors report no other conflicts of interest in this work.