Chemical Engineering Department, Loughborough University, Loughborough LE11 3TU, United Kingdom.
Curr Opin Biotechnol. 2021 Apr;68:262-271. doi: 10.1016/j.copbio.2021.02.009. Epub 2021 Mar 18.
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.
未来成功的噬菌体产业需要开发强大的可扩展制造平台，用于上游生产高噬菌体效价，并在下游进行纯化和浓缩，同时实现中间过程的加工收率。开始出现采用经过充分表征的单元操作并了解其关键工艺参数的广泛适用的工艺流程。提倡采用质量源于设计的方法来开发具有成本效益的噬菌体生产平台。讨论了在线和离线过程分析工具在过程监测、控制和质量保证方面的应用。介绍了允许合理开发液体配方和干粉形式的噬菌体生物物理特性分析工具。噬菌体封装方法的最新创新突显了该研究领域的潜在创新机会，这可能对该产业的未来前景产生重大影响。
