A photothermal acne treatment was co-developed with Sienna Biopharmaceuticals. The topical photoparticle therapy uses a high concentration formulation of silica shelled silver nanoplates that are delivered to the acne lesion via massage. When exposed to an infrared laser, thermal injury to the sebaceous gland permanently reduces oil production leading to an acne cure. During the R&D phase, nanoComposix developed a process to fabricate and encapsulate nanoplates for prototyping and proof of concept demonstration in pilot studies.

Transfer to GMP Manufacturing Under QMS

Based on the joint R&D work, a formal Product Specification was released by Sienna Biopharmaceuticals. The laboratory scale process was adapted to ensure all criteria in the Product Specifications were met. A process flow diagram was established based on the R&D process, and control points for In Process Quality Control (IPQC) were established. A Manufacturing Master Record (MMR) was developed that included Manufacturing Batch Records (MBRs) and a Bill of Materials using qualified suppliers. Process development was performed to scale the process 100×. A process Failure Mode and Effects Analysis (pFMEA) was performed to identify and address risk in the manufacture of the material. Extensive robustness work was conducted to develop a consistent process suitable for manufacture at commercial scale. Clinical supply material is now produced on-demand for the customer and scale-up for commercial production is in process.

Clinical Supply

NanoComposix supplied the nanomaterial component for all stages of development. Material was made under GMP controls for clinical trials. NanoComposix passed supplier audits to ensure the requirements of QSR and ISO 13485 were met.