Overview

Integrated Approach for Cost Reduction

M4ALL’s unique approach combines novel chemistry with the fundamental elements of process intensification. These elements include:

• Vertical integration of advanced starting materials prepared from commodity chemicals
• Consolidation of high-yielding reactions into a minimal number of unit operations with common solvents and limited intermediate isolations
• Evaluation of alternative manufacturing platforms.

 Paper Study

Paper studies enable the initial step toward establishing a benchmark of the current commercial process of a target and identifying potential cost drivers that will drive generation of strategies for cost reduction.

 Synthesis & Route Scouting

Design, develop, and implement novel & alternative synthetic routes to address primary cost drivers.

 Optimization & Multi-gram Scale up

Optimization and multi-gram synthesis of the high-yielding and cost-effective routes.

 Market Engagement and Technology Transfer

Outreach to manufacturing to implement M4ALL processes.

 Market Surveillance

Tracking of the market after release and implementation of M4ALL processes.

M4ALL has created and successfully utilized a new, integrated approach that targets those existing or novel treatments in which transformations would most positively impact global health, and ensures that M4ALL’s optimized processes can be readily translated into existing sourcing and procurement processes for immediate cost savings.

M4ALL is working with the Clinton Health Access Initiative, U.S. Agency for International Development (USAID), USAID-Global Health Supply Chain, Medicines Patent Pool, and other product development partners with supply chain and procurement resources to ensure an efficient and effective handoff to procurers and manufacturers can occur, the projected savings are realized, and the savings are documented and tracked. M4ALL has been cultivating similar relationships with other organizations that may have the disease state-specific expertise and supply chain relationships to enable them to be effective partners for other non-HIV drugs. To facilitate technology transfer and cost-saving market realization, particularly in an environment where multiple partners may be involved, M4ALL is making efforts to ensure its technology package is easy to understand and can be deployed with conventional process equipment, analytical support, and normal manufacturing skills.