SCM Pharma has secured a sterile filling and packaging project with Molteni Therapeutics, a specialty pharmaceutical company based in Italy, for a new drug substance in development for the topical treatment of infected skin lesions using the PhotoDynamic Therapy (PDT) approach.
SCM will provide product supply of an aseptically manufactured gel for a Phase II trial. This follows a successful initial collaboration for Phase I trials. The production process involves the thermal sterilization of a bulk solution before being mixed with the API and aseptically filled using isolator technology into small volume vials. The product is then labeled, randomized, packed and released to the clinical trial sites from the SCM’s MHRA-licensed facility.
Giacomo Chiti, head of analysis and bioanalysis at Molteni Therapeutics, said, “SCM Pharma demonstrated strong technical knowledge during the development stage of our project and have since shown their expertise in production and packing this investigational medicinal product. Their introduction of in-house sterility testing along with the team’s flexible approach to help meet our needs made them the ideal choice to support our scaled-up Phase II clinical trial supply needs.”