Date: February 12, 2013
Title: PATH receives follow-on funding to scale up production of thermostable influenza vaccines
Source: PATH
Summary: The Biomedical Advanced Research and Development Authority (BARDA) has awarded PATH US$2.5 million in follow-on funding to advance the development of thermostable influenza vaccines. The lead thermostable H1N1 formulations developed by PATH and technical collaborators during the initial stage of the project have shown significant improvements over control formulations, the typical stability for which is less than two weeks at 37°C. Moving forward, PATH and additional collaborators will develop a scalable production process and make it available for technology transfer, enabling vaccine manufacturers to produce seasonal and pre-pandemic vaccines with robust stability—helping to ensure vaccine performance and effectiveness under a variety of temperature conditions.
View the press release.

Date: January 25, 2013
Title: Advancing vaccine formulations of importance to developing countries using new and existing adjuvant technologies
Source: PATH
Summary: Millions of children in developing countries remain at risk of illness and disability because many vaccines that protect against certain diseases are either too expensive or not yet available. Advanced adjuvants may help to address these gaps by improving vaccine efficacy and reducing the cost per dose of vaccine delivery. Within this poster, which was originally presented at the 2012 Conference on Modern Vaccines Adjuvants and Delivery Systems, PATH highlights its work to expand access to proprietary and nonproprietary adjuvants as well as relevant formulation technologies.
View the poster.

Date: November 28, 2012
Title: New technology for producing thermostable vaccines
Source: PATH, Bend Research Inc., Fraunhofer USA Center for Molecular Biotechnology
Summary: Utilizing novel formulation and spray-drying processing methods, scientists at Bend Research Inc., PATH, and Fraunhofer USA Center for Molecular Biotechnology have developed a new technology for the production of thermostable vaccines. This technology has enabled the development of a spray-dried influenza vaccine product that is stable at 50°C for over 2 months and can also be applied to emerging influenza and other vaccines. The next phase of technical work includes the development of a commercially viable process for producing thermostable influenza vaccines using this breakthrough technology.
Read the press release.

Date: November 2012
Title: Desirable attributes of vaccines for deployment in low-resource settings
Source: Journal of Pharmaceutical Sciences
Summary: A number of product development partnerships are actively developing new vaccines to combat infectious diseases in developing countries. To be effective, the products under development should be safe, efficacious, and affordable. They should also have additional desirable technical attributes, including enhanced stability, efficient packaging, and improved ease of delivery. This commentary discusses the opportunities and challenges associated with advancing such attributes, especially vaccine thermostability and dose-sparing strategies, and the critical issues that must be addressed to bridge the gap between technology development and product development.
View the PubMed listing.

Date: October 2012
Title: Spray drying and vaccine stabilization
Source: Expert Review of Vaccines
Summary: Research on spray drying as a processing method to improve vaccine stabilization and to enable novel routes of vaccine delivery has produced promising results; however, the method has yet to be adopted for the manufacture of vaccine products by the pharmaceutical industry. This article reviews the status of spray-drying technology and discusses barriers and opportunities for its future application to vaccines.
View the PubMed listing.

Date: June 7, 2012
Title: Novel vaccine technology to transform protection of poultry and livelihoods of rural poor
Source: PATH
Summary: Commissioned by the Global Alliance for Livestock Veterinary Medicines (GALVmed) and funded through GALVmed by the Bill & Melinda Gates Foundation and the UK Government Department for International Development (DFID), PATH has developed a fast-dissolving vaccine tablet against Newcastle disease (NDV-tablet) to facilitate the immunization of “backyard poultry” (usually free range and scavengers) in low-resource settings. The main health-limiting factor for village poultry in low-resource settings is Newcastle disease—which is viral, highly contagious, and capable of destroying entire chicken populations in a short period of time. Next steps for PATH and partners include exploring the feasibility of producing NDV-tablets using equipment and materials that developing-country vaccine manufacturers already have or can easily and inexpensively access, helping to facilitate a technology transfer.
Read the press release.

Date: May 16, 2012
Title: PATH to facilitate global access to new, advanced vaccine adjuvants
Source: PATH
Summary: In collaboration with key technology partners including the Vaccine Formulation Laboratory at the University of Lausanne (UNIL) in Switzerland, PATH has launched an innovative project to facilitate global access to new, advanced adjuvants and formulation technologies—with the aim of accelerating the development and introduction of critical, lifesaving vaccines. Under the project, PATH and partners will focus on evaluating novel adjuvants for potential use in the development of an effective and affordable adjuvanted formulation of inactivated polio vaccine (IPV). A later phase of the project may involve the development of adjuvanted formulations for vaccines against malaria, rotavirus, AIDS, or tuberculosis.
Read the press release.

Date: September 15, 2010
Title: PATH awarded $5.2 million BARDA contract to stabilize pandemic influenza vaccines
Source: PATH
Summary: PATH has been awarded a $5.2 million contract from the Biomedical Advanced Research and Development Authority (BARDA), a division of the US Department of Health and Human Services, to develop stable formulations of both live and subunit influenza vaccines. In collaboration with Arecor Limited and Aridis Pharmaceuticals, PATH will focus its work on extending the product shelf life of pandemic influenza vaccines to facilitate vaccine stockpiling and rapid deployment of fully potent vaccines independent of the vaccine cold chain, activities that could significantly help to contain future influenza pandemics. Under this contract, PATH and partners aim to create new formulations with improved stability and investigate the manufacturability, regulatory pathways, and economic benefits of select formulations when adopted and used at large scale.
Read the press release.

Date: August 2010
Title: Vaccines with aluminum-containing adjuvants: optimizing vaccine efficacy and thermal stability
Source: Journal of Pharmaceutical Sciences
Summary: Use of aluminum-containing adjuvants to enhance immune responses is not new. Aluminum adjuvants have been in use in vaccines for decades. However, exposure of vaccines containing these adjuvants to temperatures outside of the recommended storage ranges (especially exposure to freezing temperatures) puts the vaccines at risk. In this article, PATH and partners discuss how optimizing the stability of alum adjuvanted vaccines requires an understanding of the freeze sensitivity of the adjuvant and the freeze and heat sensitivity of the antigen in the presence of the adjuvant. The authors also survey the different formulation approaches that can be used to increase the stability of these vaccines, helping to improve their effectiveness.
View the PubMed listing.

Date: July 2010
Title: Thermostable formulations of a hepatitis B vaccine and a meningitis A polysaccharide conjugate vaccine produced by a spray-drying method
Source: Vaccine
Summary: Research employing a spray-drying process to produce glassy state formulations of two common subunit vaccines demonstrates that the production of thermostable vaccines is achievable. The process was tested on recombinant hepatitis B vaccine containing aluminum adjuvant and meningitis A protein-polysaccharide conjugate vaccine. The spray-dried hepatitis B formulations remained stable for at least 24 months at 37°C, and several of the meningitis A formulations were completely stable at temperatures up to 60°C for at least 2 weeks, which is when the test ended.

Date: July 2010
Title: Designing vaccines for developing-country populations: ideal attributes, delivery devices, and presentation formats
Source: Procedia in Vaccinology
Summary: In this article, Debra Kristensen, group leader of Vaccine Technologies at PATH, and Michel Zaffran, senior advisor, Immunization, Vaccines, and Biologicals at the World Health Organization, discuss the importance of designing vaccines with traits that will minimize complications for immunization programs and increase the likelihood of successful adoption. The article also summarizes specific recommendations for vaccine producers and developers, as outlined by the Vaccine Presentation and Packaging Advisory Group.
Search for the journal article on the Science Direct website.

Date: June 15, 2010
Title: The Cool Chain
Source: BBC Radio, World Service
Summary: In this special report, Geoff Watts investigates the science, politics, and economics of the global vaccine cold chain. Various experts are interviewed, including Mobido Dicko (World Health Organization), Oz Mansoor (UNICEF), Mercy Ahun (GAVI Alliance), and Debra Kristensen, PATH’s group leader of Vaccine Technologies.
Listen to the program at BBC Radio.

Date: March 2010
Title: Stabilization of vaccines: lessons learned
Source: Human Vaccines
Summary: In this guest editorial, PATH explores the key logistical, regulatory, procurement, and policy issues associated with the development and use of temperature-stabilized vaccines. Authors Debra Kristensen, group leader of vaccine technologies, and Dexiang Chen, lead vaccine formulation scientist, reflect on nearly 8 years of work to optimize the heat- and freeze-stability of 7 types of vaccines with 33 collaborators.
Read the editorial in Human Vaccines.

Date: January 1, 2010
Title: Developing a vaccine that is stable at room temperature for 8 weeks
Source: Pharmaceutical Technology Europe
Summary: Dr. Satoshi Ohtake, a senior scientist at Aridis Pharmaceuticals, details research efforts conducted in collaboration with PATH which resulted in the formulation and development of an improved measles vaccine formulation that is stable for at least 8 weeks at 37°C. This article is based on a presentation given by Dr. Ohtake at the 2009 American Association of Pharmaceutical Scientists Annual Meeting and Exposition.
Read the article on the PharmTech website.

Date: January 2010
Title: Heat-stable measles vaccine produced by spray drying
Source: Vaccine
Summary: Scientists at Aridis Pharmaceuticals and PATH have produced heat-stable measles vaccine powder using a combination of unique stabilizers and mild spray-drying process conditions. Spray drying was identified as the optimal processing method for the preparation of dried vaccine, as it generally resulted in negligible process loss and comparable, if not better, storage stability compared to other processes. Processing methods and formulation components were developed and a measles vaccine was produced that was stable for up to 8 weeks at 37°C, which surpassed the World Health Organization requirement for heat stability of 1 week at that temperature. Key stabilizers identified during the formulation screening processes were L-arginine, human serum albumin, and a combination of divalent cations.

Date: November 1, 2009
Title: Efforts to improve vaccine stabilization heat up
Source: Nature Medicine
Summary: Here, Nature Medicine reports that freeze protection for hepatitis B and potentially other alum-adjuvanted vaccines may be at hand. Senior Contributor Meredith Wadman examines PATH’s development of a hepatitis B vaccine formulation that does not lose potency after repeated freezing at minus 20°C. Wadman also explores PATH’s recent progress—in collaboration with Arecor Limited—at addressing the more widely recognized problem of heat damage to vaccines. Discussion of the advancements and the challenges in developing formulations that help to protect vaccines from damage caused by exposure to heat and cold are framed within the context of technologies that are meant to improve global health.
Article available to subscribers on the Nature Medicine website.

Date: September 1, 2009
Title: New innovation makes vaccines more resilient
Source: Worldchanging
Summary: Temperature regulation is one of the biggest challenges to vaccine use worldwide. PATH’s group leader for Vaccine Technologies, Debra Kristensen, recently discussed with Aman Bhandari—co-founder of Global Health Ideas and contributor to Worldchanging—the impact that protecting vaccines from heat and cold could have on global health. Here, the conversation focuses on breakthrough achievements by PATH and partners in temperature regulation of hepatitis B vaccine.
Read the article on the Worldchanging website.

Date: August 4, 2009
Title: PATH scientists discover cheap, easy way to protect vaccines from hot and cold
Source: Xconomy
Summary: Scientists at PATH have found a cheap and simple way to tackle the challenges associated with protecting hepatitis B vaccine effectiveness when the vaccine gets too hot or too cold. Here, Luke Timmerman, the national biotechnology editor for Xconomy.com, reports on PATH's recent success in applying heat and freeze stabilization technologies to hepatitis B vaccine.
Read the article on the Xconomy website.

Date: August 3, 2009
Title: PATH develops technology that protects hepatitis B vaccine from heat and freeze damage
Source: PATH
Summary: PATH scientists and collaborators have developed formulation methods that protect hepatitis B vaccine from heat and freeze damage. In partnership with Arecor and the University of Colorado Denver School of Pharmacy, PATH developed a new hepatitis B vaccine formulation exhibiting nine-week stability at 55°C and at least six-month stability at both 37°C and 45°C. Further testing found the new hepatitis B vaccine formulation to be heat-stable for 12 months at 37°C in addition to proving freeze-stable at −20°C.
Read the press release.

Date: August 2009
Title: A heat-stable hepatitis B vaccine formulation
Source: Human Vaccines
Summary: A collaborative effort between PATH, Arecor, and the University of Colorado Denver School of Pharmacy has resulted in a new formulation for recombinant hepatitis B vaccine that demonstrates improved stability at elevated temperatures. The formulation exhibited nine-week stability at 55°C and was also shown to be stable at both 37°C and 45°C for at least six months. This new vaccine formulation has the potential to be stored at room temperature for part of its shelf life and will help ensure the potency of the vaccine in areas where the cold chain is insufficient.
Read the journal article.

Date: July 23, 2009
Title: Characterization of a thermostable hepatitis B vaccine
Source: Vaccine
Summary: A new hepatitis B vaccine formulation developed and tested by PATH scientists and partners at Arecor and the University of Colorado Denver School of Pharmacy has proven stable against repeated freezing at −20°C. In addition, it has proven stable for 12 months at 37°C. The formulation was also found to be well tolerated in rabbits without any significant local or systemic side effects. Overall, the improved stability of this hepatitis B vaccine could be a key factor in ensuring vaccine effectiveness, extending immunization coverage, simplifying immunization logistics, and reducing the costs associated with the cold chain.

Date: May 1, 2009
Title: Opportunities and challenges of developing thermostable vaccines
Source: Expert Review of Vaccines
Summary: This article reviews approaches being used to develop thermostable vaccine formulations that would be resistant to damage caused by freezing or excessive heat, and that could reduce dependence on the cold chain. The challenges associated with the implementation of these novel formulations are discussed, as well as the potential benefits of protecting vaccines from damage caused by breaks in the cold chain.
Read the journal article.

Date: May 1, 2009
Title: Technology solutions for global health, vaccine stabilization
Source: PATH
Summary: As part of PATH’s series on technology updates in Global Health, this fact sheet describes PATH's latest achievements and scope of work in vaccine stabilization (as of May 2009).
Read the fact sheet.

Date: January 21, 2009
Title: Seattle-based PATH develops new ways to protect vaccines
Source: Seattle Post-Intelligencer
Summary: No one knows how many children worldwide receive vaccines rendered useless from exposure to extreme temperatures during storage and distribution, but Seattle-based PATH has come up with yet another way to prevent this problem.
Read the article on the Seattle Post-Intelligencer website.

Date: January 21, 2009
Title: PATH develops technology that protects lifesaving vaccines from freeze-damage
Source: PATH
Sumary: PATH scientists have developed a vaccine formulation method that preserves the effectiveness of specific types of vaccines even after repeated exposure to freezing. This formulation method is applicable to vaccines containing aluminum adjuvants—including hepatitis B, diphtheria, tetanus toxoid, and pertussis vaccines.
Read the press release.

Date: January 1, 2009
Title: Development of a freeze-stable formulation for vaccines containing aluminum adjuvant
Source: Vaccine
Sumary: Vaccines containing aluminum salt adjuvants are prone to inactivation following exposure to freeze–thaw stress. Here, scientists describe an approach to protect vaccines from freeze–thaw inactivation. By including polyethylene glycol 300, propylene glycol, or glycerin in a hepatitis B vaccine, particle agglomeration, changes in the fluorescence emission spectrum—indicative of antigen tertiary structural changes—and losses of in vitro and in vivo indicators of potency were prevented following multiple exposures to −20°C.
Read the journal article.

Date: December 2008
Title: Summary of stability data for commonly used vaccines and novel vaccine formulations
Source: PATH and Working in Tandem, Ltd.
Sumary: PATH summarizes stability data for commonly used vaccines as well as research efforts to improve the stability of these products.
Read the summary.

Date: July 2007
Title: An economic evaluation of thermostable vaccines in Cambodia, Ghana, and Bangladesh
Source: Vaccine
Summary: Single-dose presentations of thermostable vaccines are potentially cost-effective interventions to reduce childhood deaths and disability in low-resource settings in Asia and Africa. This paper evaluates the incremental health and programmatic cost impacts of theoretical new vaccine products as compared to the standard vaccine products in multi-dose vials in Cambodia, Ghana, and Bangladesh. The authors use a cost-effectiveness model to estimate the impacts of introducing four thermostable vaccines with single-dose presentations: measles, yellow fever, bacille Calmette-Guerin, and diphtheria–tetanus–pertussis–hepatitis B. The effectiveness of all of the vaccines increases with the thermostable formats. The incremental costs associated with the introduction of thermostable vaccines increases for three out of four vaccines.
Read the journal article on the JournalsConsult website.