Robust Approaches for the Production of Active Ingredient and Drug Product for Human Phage Therapy.

ABSTRACT: To be successful, academic and commercial efforts to reintroduce phage therapy must ensure that only safe and efficacious products are used to treat patients. This raises a number of manufacturing, formulation, and delivery challenges. Since phages are biologics, robust manufacturing processes will be crucial to avoid unwanted variability in each step of the process. The quality standards themselves need to be developed, as patients are currently being treated with phages produced under quality standards ranging from cGMP for clinical trials in EMA and FDA regulated environments to no standards at all in some last resort treatments. In this short review, we will systematically review the literature covering technical issues and approaches to increase robustness at every step of the product

SUBMITTER: Mutti M 

PROVIDER: S-EPMC6791927 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature