Strengthening the global vaccine supply
PATH is improving access to essential, high-quality, affordable vaccines through initiatives like our Sustaining Vaccine Manufacturing (SVM) program. We support emerging market vaccine manufacturers in accessing state-of-the-art technology and in developing and sustainably producing vaccines that meet international quality standards and address global health priorities.
Our philosophy
The world needs competitive vaccine markets that include vaccine manufacturers from countries with low- and middle-income economies. When new manufacturers enter the market, supply increases and costs decrease— and access to new and improved vaccines can occur more quickly and become more stable. By increasing the number of global producers we can ensure a reliable and continuous vaccine supply—an essential component to global health security.
We provide end-to-end support from facility design to navigating WHO prequalification to maintaining regulatory standards over time. We work with manufacturers in all corners of the world and on a wide variety of pathogens and have advanced more than a dozen lifesaving vaccines to the global market.
We work to understand the low- and middle-income country vaccine manufacturing ecosystem to identify challenges and opportunities for growth. For example, we partnered with the Africa Centres for Disease Control and Prevention and the Clinton Health Access Initiative to assess current and planned vaccine manufacturing capacity in Africa, with an update one year later. This work can ensure alignment among stakeholders, governments, and funders and lead to more strategic investments and interventions.
We improve access to and affordability of resources and technology that can ensure accurate and reliable vaccine manufacturing in low- and middle-income country settings. For instance, we're working to develop standardized approaches to mRNA potency assays that can easily be adapted in low resource settings, and are building internal expertise with lipid nanoparticle formulation platforms for mRNA vaccine production that can be shared with emerging market vaccine manufacturers.
We connect manufacturers across the world so they can mutually benefit from exchanged expertise, shared resources, and collaborative learning opportunities. We host webinars that offer a deep dive on critical aspects of vaccine manufacturing, including aluminum adjuvants and adventitious egg-based agents, and convene and manage the RNA Cooperative, an initiative to advance RNA vaccine manufacturing in low- and middle-income countries.
We work to ensure emerging market vaccine manufacturers can more easily access materials that aren't readily available but that are necessary to advance manufacturing and conduct clinical studies. We explore different avenues for procurement, from working with wholesalers to facilitating exchange between countries to building a supply of materials in-house. For instance, our work has generated supplies of high-quality HPV and COVID-19 monoclonal antibodies that can be made available to low- and middle-income country vaccine manufacturers.
This fact sheet describes PATH's technical assistance work with low- and middle-income country vaccine manufacturers and the Sustaining Vaccine Manufacturing program.
This fact sheet details successes from PATH's Sustaining Vaccine Manufacturing program to improve global access to essential, high-quality, affordable vaccines.
This fact sheet describes Chemistry, Manufacturing, and Controls (CMC) work at PATH.
This webinar features experts in the field, and covers chemistry and immunobiology of aluminum adjuvants; good manufacturing practices for producing aluminum-based vaccine adjuvants; approaches for modulating immune response quality; advancements in alum+ adjuvants; and lessons learned.
This webinar features experts in the field and helps manufacturers understand recent regulatory guidelines and analytical and cell culture technologies used in the vaccine industry for adventitious egg-based vaccine production of viral vaccines.
This webinar discusses the practical applicability of NGS sequencing for vaccine development and testing by low- and middle-income country manufacturers. It provides up-to-date information and guidance from subject matter experts on NGS methodology, validation, regulatory expectations, and controls; and features two real-world case studies and a panel discussion between regulatory experts.
New scientific publication
Comparing benchtop LNP production platforms for mRNA vaccines
Read the articleOur expertise
All vaccine technologies and platforms
Analytical methods development and validation
CMC regulatory affairs
Drug substance process development and manufacturing
Drug product process development and manufacturing
Due diligence and audit
Facility design, qualification, and remediation
Facility due diligence and audit
Logistics and supply chain for materials and reagents
Manufacturing strategy planning
Nonclinical toxicology
Quality management systems
Streamlining of management and operations