In Conversation: Sean Kirk, Emergent BioSolutions

Following up on the recent article Two Maryland Biotechs Partner to Bring Coronavirus/COVID-19 Vaccine Candidate into Clinical Trials, BioBuzz had the opportunity to speak with Emergent BioSolutions Executive Vice President, Manufacturing and Technical Operations, Sean Kirk.

Let’s start by having you provide a brief background on your role at Emergent.

I have been with the company for nearly 17 years, and have had the good fortune of working in and being responsible for many key parts of the business including manufacturing operations, quality assurance, regulatory affairs, product development, U.S. government program management, global operational excellence, global supply chain, medical and clinical affairs. In these roles I have spent a lot of time across Emergent’s sites and have been based in Lansing, Mich. – where I started – Gaithersburg, Md, and Winnipeg, Manitoba. I am currently responsible for the oversight of global manufacturing operations, supply chain management, global operational excellence, medical/clinical/regulatory affairs, and our CDMO Business Unit, and I am based out of our headquarters in Gaithersburg.

With the evolving news around COVID-19 and your partnership with Novavax being announced last week to work on a vaccine, what can you tell us about Emergent that most people wouldn’t know?

For 22 years, Emergent’s mission has remained the same – to protect and enhance life. Our focus has been on products and services that address serious public health threats, such as biological and chemical warfare agents, emerging infectious diseases, and opioid overdoses. The current COVID-19 challenge we are facing is complex and Emergent is committed to a multi-faceted response as we marshal our resources, such as the capabilities, capacities, and expertise of our network in support of our Contract Development and Manufacturing Organization (CDMO) Business Unit. For COVID-19 specifically, three of our Maryland facilities are involved, including our Gaithersburg labs, our Emergent Bayview facility in Baltimore, which is designated as a Center for Innovation in Advanced Development and Manufacturing (CIADM) by the U.S. Department of Health and Human Services (HHS), and our Camden fill/finish facility, which is also in Baltimore. We also have our decades-long history in vaccines and therapeutics to offer.

I’m glad you brought up Emergent’s Bayview facility in Baltimore, what can you tell us about its history and capabilities?

Emergent’s CIADM is a result of a public-private partnership with the Biomedical Advanced Research and Development Authority (BARDA) at HHS. We are entrusted to play a role in public health emergencies, and we take this responsibility seriously. Since our designation as CIADM in 2012, Emergent has responded to U.S. government task orders to develop therapeutics for viral hemorrhagic fevers, including Ebola, and a Zika vaccine.

We are proud that our CIADM is serving the purpose for which it was established and thank BARDA for its partnership and foresight in investing in such capabilities that have helped enable our rapid response to the current COVID-19 challenge.

Our CIADM has the capacity to produce tens to hundreds of millions of doses of vaccine annually, based upon the platform technology being leveraged. That capability encompasses clinical scale production meant to get vaccine candidates quickly into the clinic and, in parallel, the scale up to commercial volumes.  

Back to your partnership with Novavax. How will this collaboration help with the development of a vaccine to fight COVID-19?

Emergent will produce Novavax’s COVID-19 experimental vaccine candidate, which is based on their proprietary recombinant protein nanoparticle technology platform and utilizing their proprietary Matrix-M™ adjuvant to enhance immune responses. Emergent has initiated work for this program anticipating that the COVID-19 experimental vaccine candidate will be used in a Phase 1 clinical study within the next four months.

You mentioned Emergent’s decades of experience and your work with HHS. What else can you tell us about your partnership with the government?

To expand on what I mentioned earlier, Emergent has partnered with the U.S. and allied governments to serve their national security and preparedness and response needs. We have a longstanding history of successfully developing, manufacturing, and delivering medical countermeasures against serious threats like anthrax, smallpox, botulism, and chemical warfare agents.

In the face of public health challenges, we stand proud of our nimble response and our ability to rapidly deploy our capabilities, capacities, and expertise where we can make an impact. We are especially proud and thankful to our approximately 1,800 dedicated employees who are committed to our mission – to protect and enhance life – and getting the job done as expeditiously as possible.