Approaches for manufacture, formulation, targeted delivery and controlled release of phage-based therapeutics.

A future successful bacteriophage industry requires development of robust scalable manufacturing platforms for upstream production of high phage titres and their downstream purification and concentration whilst achieving processing yields en route. Development of a broadly applicable process flow sheet employing well-characterised unit operations with knowledge of their critical process parameters is beginning to emerge. A quality-by-design approach is advocated for the development of cost-effective phage production platforms. The use of on-line and at-line process analytical tools for process monitoring, control and quality assurance are discussed. Phage biophysical characterisation tools allowing rational development of liquid formulations and dry powder forms are presented. Recent innovations in phage encapsulation methods highlight the potential innovation opportunities in this research space that could have significant impact on the future prospects of this industry.