MAPs for PrEP: Manufacturing Strategy and Cost Analysis

The project seeks to develop a dissolving MAP for delivery of long-acting HIV PrEP to the point of phase 1 clinical readiness. Additionally, the project explores the potential of a segmented, dissolving MAP for delivery of long-acting HIV PrEP and a long-acting hormonal contraceptive through proof of concept. Key features of the desired MAP product include self-administration with a feedback indicator to confirm successful application, a short wear time of less than 20 minutes, and weekly or monthly dosing. The project also aims to integrate the MAP into healthcare delivery systems. The project leadership team includes a manufacturing advisor, a CAB provider and technical advisor, user study advisors, and formulation and preclinical development experts. Preclinical development is a key area of focus for the project, involving the characterization and optimization of MAP formulations, conduct of preclinical bench and animal testing, and the establishment of a product development pathway. The project also conducts cost of manufacturing and cost of delivery analyses to evaluate the suitability and affordability of the proposed MAP and potential future adoption. A cost of goods sold (COGS) analysis is performed to determine the production cost per dose of the proposed CAB MAP, and a cost of delivery analysis is conducted to compare the CAB MAP to other forms of PrEP. The project partners with various organizations, including CHDC, to conduct country assessments and evaluate stakeholder and end user acceptability. The project also establishes research partnerships and implements capacity-building workshops to support the development of the MAP technology. The manufacturing strategy for the MAP involves developing a novel product with dose-sizes required for the CAB active pharmaceutical ingredient (API), which represents a paradigm shift within an emerging technology landscape. The project aims to build a body of knowledge and test boundaries previously untested within the MAP industry. The MAP technology consists of hundreds of tiny projections (<1 mm) that deliver dry vaccines or drugs into the skin. The MAP is applied to the skin like a bandage, and the projections dissolve upon contact with interstitial fluid to release the active pharmaceutical ingredient. Wear times range from a few seconds to hours, depending on the design, and once dissolved, the MAP backing is removed and discarded. The technology has the potential to provide a convenient and effective method for delivering HIV PrEP and other medications.