Vaccine and Pharmaceutical Formulation and Stabilization Technologies

Overview

Our scope of work in vaccines and pharmaceutical research

By bridging translational research and product development, PATH’s work in the space of vaccine and pharmaceutical research prioritizes the exploration and advancement of novel technologies and processing methods that help to achieve the following specific product attributes of critical importance to vaccines and essential medicines in low-resource settings:

  • Enhanced product efficacy. When properly formulated, adjuvants can help to improve vaccine efficacy, augmenting the breadth and magnitude of the immune response to a vaccine. Adjuvanted formulations can also be designed to target a specific or desired type of immune response, including humoral, cell-mediated, or mucosal immunity. In addition, some adjuvants have been shown to reduce the dose required per person, potentially helping to decrease vaccine costs. Visit our page on enhancing product efficacy to learn more »
  • Optimized product stability. Improvements in stability can allow for product use at elevated temperatures, better enabling the distribution and use of vaccines and essential medicines in settings where cold chain systems are unreliable or where a longer shelf life could help prevent stockpile turnovers (as for pre-pandemic vaccines). Improved stability of alum-adjuvanted vaccines at low temperatures is also valuable, given high rates of exposure to freezing temperatures in the cold chain, which can reduce the potency of freeze-sensitive vaccines. Visit our page on optimizing product stability to learn more »
  • Novel product formats. Vaccines administered directly to the mucosa can preferentially activate key cells, helping to trigger important antibodies. For certain drugs, administration via the mucosal route—particularly sublingually (i.e., under the tongue)—offers similar advantages due to its high permeability and proximity to rich blood supply, both of which help to produce a rapid onset response. This type of response is especially useful for drugs with short delivery period requirements or involving infrequent dosing regimens.
  • In addition, the mucosal delivery route does not require the use of sharps, thus eliminating the risk of needlestick injuries and needle reuse. PATH recently developed a technology platform viable in two needle-free product formats that builds on several proven formulation, adjuvant, and delivery technologies to enable the sublingual administration of subunit vaccines. Additional vaccine and drug applications are also in development. Visit our page on novel product formats to learn more »

Our teams regularly work with developers and manufacturers to apply adjuvant and stabilization formulation technologies to new vaccine and pharmaceutical products as they are developed. To accelerate technology transfers, we work to ensure that manufacturability is determined, process efficiencies are gained, and regulatory pathways are established, where appropriate. In addition, we are equipped to provide onsite training on the development and production of scalable batches of liquid and dry formulations.

Commitment to collaboration

Many of our achievements are rooted in effective collaborations with public- and private-sector partners, including numerous product development partnerships (PDPs). These partners include governments, vaccine and technology companies, research laboratories, universities, research consortia, international agencies, and other nongovernmental organizations.

Our work with PDPs and other public- and private-sector collaborators begins with the shared goal of improving global health, builds on respect for each partner’s contributions, and proceeds after a detailed assessment of joint interests and capabilities. To ensure the affordability and availability of new technologies, PATH has developed guidelines for working with the private sector, including approaches to managing intellectual property that serve both private and public interests.

We also have extensive experience in administering the financial, budgetary, and reporting aspects of multiparty research and development projects as prime contractor as well as establishing collaborative research agreements, subcontracts, and material transfer agreements with technology companies and major vaccine producers.

Our formulation and stabilization project activities have been supported with funding from government agencies (both US and foreign), private foundations, individual donors, commercial partners, and academic research institutes, among other agencies and funding bodies.

Additional information