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

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