DDL’s CMC manager presented at AAPS 2018 “Formulation and regulatory considerations for developing topical live biotherapeutic products”


Jason Carbol, CMC Manager and Senior Formulator at DDL, gave a presentation Tuesday, November 4, 2018 at the Walter E Washington Convention Center in Washington DC, prompted by growing interest by the scientific community and the FDA around the role of microorganisms in the treatment and prevention of disease.

Mr. Carbol’s talk covered existing regulatory requirements and specifically how they apply to formulation development of topically applied live biotherapeutic products (microbiome-derived active ingredients).  Formulating topical products with live bacteria, probiotic and/or bacteriophages presents unique challenges. Important factors such as preservative systems and gelling agents into what is a sensitive system were presented. Considerations such as effect of pH and osmolality on stability and activity of microbes were shared as well as importance of how evolving regulatory requirements may direct development.