Harro Höfliger, a global leader in pharmaceutical process engineering and sterile manufacture, and Vaxxas, a clinical‐stage biotechnology company commercializing a novel vaccination platform, today announced an alliance to develop the world’s first high‐throughput, aseptic manufacturing line for production of vaccine products based on Vaxxas’ HD‐MAP technology.

Allmersbach im Tal, Germany; Cambridge, Mass., USA; Brisbane, Australia, May 28, 2020 –
  • Needle‐free Vaxxas HD‐MAP can enhance routine vaccination with potential to revolutionize vaccination in pandemic response; produce more patient‐doses from limited quantities of vaccine, distribution without refrigeration, and potential for self‐administration.
  • Collaboration lays engineering groundwork for capital expenditure investments of up to $25 million over the next 3 years.
  • Harro Höfliger and Vaxxas will develop world’s first high‐throughput aseptic line for vaccine‐HD‐MAP production; capacity of compact modular lines targeted at 5 million units per week.
  • Vaxxas HD‐MAP enhances immune response; recent clinical study shows that 1/6 dose of influenza vaccine by HD‐MAP produced comparable immune response to full dose injection by needle/syringe. Vaccine on HD‐MAP was stable for 12 months at temperatures as high as 40oC.

Single, aseptic‐based lines will have a targeted throughput of up to 5 million vaccine products/week. Initial efforts are focused on a pilot line operating in 2021 to be used to support late‐stage clinical studies.

“We’re excited to be working on this project with Harro Höfliger,” said David L. Hoey, President and CEO of Vaxxas. “A major challenge in commercializing microarray patches – like Vaxxas’ HD‐MAP – for vaccination is the ability to manufacture at industrially‐relevant scale, while meeting stringent sterility and quality standards. Our novel device design along with our innovative vaccine coating and quality verification technologies are an excellent fit for integration with Harro Höfliger’s aseptic process automation platforms. Adopting a modular approach, it will be possible to achieve output of tens‐of‐ millions of vaccine‐HD‐MAP products per week.”

Vaxxas HD‐MAP is a 9x9mm array of thousands of very short (~250μm) projections, invisible to the naked eye, coated with vaccine. Application of the HD‐MAP to the skin quickly delivers vaccine to abundant populations of immune cells. In a recent clinical study, the HD‐MAP demonstrated that 1/6 dose of influenza vaccine by Vaxxas’ HD‐MAP resulted in comparable immune response to full dose by intramuscular injection and 2/3 dose by HD‐MAP was capable of generating significantly faster and higher overall antibody responses. Because vaccine is dried onto the HD‐MAP, vaccines can be stable outside of cold‐chain; vaccines in the clinical study were verified to be stable at 40oC for 12 months.

“Harro Höfliger has an extensive track‐record of bringing new pharmaceutical and medical device technologies from lab‐scale to the production levels necessary for industry,” said Thomas Weller, CEO of Harro Höfliger. “Sterile processing adds additional complexity and our engineering development team and aseptic experts have a lot of experience in the development of new and customized processes for fully automated equipment in an aseptic environment. We’re looking forward to developing high‐ throughput aseptic production lines for the HD‐MAP with the team at Vaxxas.”

For routine infectious disease more than 750 million vaccinations are given worldwide each year by needle/syringe in advanced markets as well as lower‐ and middle‐income countries. In the case of pandemic response, billions of vaccinations may need to occur in a variety of settings. Vaxxas’ HD‐MAP has the potential to create new needle‐free vaccine products with enhanced immune response and designed for improved safety, storage, and distribution logistics to extend the reach of vaccines and improve vaccination efficiency and effectiveness.