From a small biotech start-up firm in Allentown, Pennsylvania, two scientists are leading their team to bring an oral COVID-19 vaccine to market – one that will be easier to use, longer lasting and with fewer side effects.
Kyle Flanigan and Garry Morefield co-founded US Specialty Formulations LLC (USSF) through discussions while watching their daughters compete in gymnastics. This came with just $100,000 and the ambition to grow their site into a thriving biotech and pharmaceutical facility. Today, the 41,000-square-foot manufacturing facility spans more than two acres and has become a hub of experts creating diverse solutions, applications and approaches to help clients overcome hurdles in drug discovery and development.
US Specialty Formulations is a minority-controlled business and certified Current Good Manufacturing Practice (cGMP) manufacturer of sterile injectable, topical and specialty pharmaceuticals. It manufactures its own branded prescription products and provides clinical materials for investigational new drug applications, specialty formulations, adjuvants and fermentation and purification services requested by various biotech companies.
The US Specialty Formulations team applies agile high-performance teams system to facilitate collaboration and problem solving – ensuring clients’ products go to market efficiently and seamlessly. From initial stages of development to commercial manufacture, they leverage their methods, analytics, scale-up technologies and technology transfer to guide small compound and vaccine development.
With a portfolio that includes a range of vaccine candidates, small molecule formulations and botanical pharmaceutical grade extracts, Flanigan and Morefield are bringing their mucosal COVID-19 vaccine to market. They pivoted their formula from an oral DTaP (diphtheria), a childhood vaccine most of the population received, initially targeted for human clinical trials in early 2020.
How has US Specialty Formulations been able to adapt the DTaP vaccine for COVID?
In the early pre-clinical development work, we looked at extending the shelf life of existing vaccines using this oral technology. For those experiments, we used an expired DTap vaccine. The experiments showed that after applying our technology to the expired DTap vaccine, it generated immune responses on par with a ‘fresh’ vaccine vs. a poor immune response from the unmodified and expired stock DTap vaccine. The current oral platform benefited from these early experiments and the learnings incorporated into the COVID vaccine.
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