The mission of the Dermatology Summit, an Advancing Innovation in Dermatology conference, is to build a community of people who are excited about innovation in dermatology. DDL will once again be a sponsor and exhibitor. Please register and join us for the virtual conference on January 8, 2021.
DDL’s CMC Manager, Jason Carbol, describes current trends and overcoming challenges in topical product manufacturing, scale up and packaging with Pharmaceutical Technology for their March 2020 publication. Key topics include variability of dosing topical products in the clinic, unique scale up challenges with respect to semi-solid drug products, and the complicated nature of semi-solid product development.
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.