Novavax is Building a Global Tech Transfer Team to Rapidly Deliver 2 Billion COVID-19 Vaccine Doses Around the World
Gaithersburg, Maryland’s Novavax has skyrocketed to national and global prominence during the coronavirus pandemic. In an incredibly short time, the company has advanced its SARS-CoV-2 vaccine candidate into Phase III trials and received FDA fast track designation.
In late February 2020, Novavax announced that its COVID-19 vaccine candidate had made progress in animal models. Just a few months later, the company secured $388M in funding from the Coalition for Epidemic Preparedness and Innovation (CEPI). In June and July, Novavax received an influx of funding from the Department of Defense (DoD) and Operation Warp Speed, the latter providing $1.6B in vaccine funding. Just six months later in August 2020, Novavax announced positive Phase I data, which was followed by the start of Phase II clinical trials that same month. In September, Novavax’s Phase III trials in the U.K. commenced and the company received Fast Track Designation from the FDA in early November of this year.
Novavax has committed to being able to produce approximately 2B NVX-CoV2373 doses annually once approved. This is the largest commitment of any COVID-19 vaccine developer, which will be a remarkable feat for the small Maryland-based biotech that is still a clinical stage company without a large scale manufacturing facility. So, why is there so much demand for the NVX-CoV2373 vaccine and how can such a small biotech meet this large demand?
What it all comes down to is that NVX-CoV2373 is a more easily delivered vaccine that is better suited for global distribution.
NVX-CoV2373 stands apart from several other SARS-CoV-2 vaccine candidates in later-stage clinical trials. Specifically, Pfizer and Moderna require cold storage temperatures that range from minus-20 degrees Celsius (Moderna) to minus-70 degrees Celsius (Pfizer) which will require stricter cold chain logistics and storage requirements that many healthcare facilities may not have access to. This makes the distribution and storage of the vaccines to patients across the globe, one of the most complex logistical challenges facing the global vaccine campaign.
Novavax’s NVX-CoV2373 offers an attractive option because it can be stored at refrigerator temperature using the existing healthcare infrastructure. The vaccine will be shipped ready-to-use and will not require additional steps, such as admixing or reconstitution. These characteristics help make Novavax’s vaccine’s delivery, both to the market and into COVID-19 patients, much simpler than candidates that have colder transport and storage requirements.
Novavax is executing a strategy that is focused on an industry-leading tech transfer team, global collaboration, and a vibrant, mission-driven workplace culture that will ensure it meets its commitment to delivering it’s vaccine to the public.
According to John Kutney, Senior Director of Manufacturing, “The challenge of rapid development is about taking a process in a highly regulated industry that normally spans years and crunching the timeline without taking too much risk. Our team has been successful by being decisive, being open to new ideas, and regularly re-evaluating the approach as new information is learned.”
Rapidly developing an effective and safe vaccine means little if you can’t scale the production and get it to the people that need it in sufficient numbers. To solve this challenge, Novavax has made remarkable strides in establishing and expanding its manufacturing and distribution capabilities across three continents.
Novavax signed a vaccine manufacturing agreement with Emergent Biosolutions shortly after the pandemic outbreak. In May 2020, Novavax acquired India’s Praha Vaccines for $167M in cash, adding a vaccine manufacturing facility to its portfolio. Novavax announced in July 2020 that it had an agreement in place with FUJIFILM Diosynth Biotechnologies (FDB), a world-leading contract development and manufacturing organization (CDMO) for biologics, viral vaccines, and gene therapies to manufacture bulk drug substance for NVX-CoV2373.
August saw Novavax forge a partnership with South Korea’s SK Biosciences for assistance in producing an antigen component for its vaccine candidate. That same month the company announced a partnership with the Japanese company Takada. What’s more, the company announced in September 2020 an amended partnership with the Serum Institute in India, which increased its global production capacity to its promised 2B dose level when all manufacturing capacity is online in 2021.
A summary of their manufacturing network, as outlined in a recent press release, showcases the breadth of their global footprint.
The antigen component of NVX-CoV2373 is being manufactured at Novavax CZ in Bohumil, Czech Republic (formerly Praha Vaccines), as well as at the following partnered manufacturing sites:
- Biofabri in Spain
- FUJIFILM Diosynth Biotechnologies (FDB) in both North Carolina and Texas in the United States
- FDB in the United Kingdom
- SIIPL in India
- SK Bioscience in the Republic of Korea
- Takeda Pharmaceutical Company Limited in Japan
Novavax’ Matrix-M adjuvant is now being manufactured at Novavax AB in Uppsala, Sweden and the following partnered manufacturing sites:
- AGC Biologics in the United States and Denmark
- PolyPeptide Group will manufacture two key intermediaries used in Matrix-M in the United States and Sweden.
In just seven months, Novavax scaled up and expanded its manufacturing and distribution network across the U.S. and the globe. With its global network now in place, the important work of effectively transferring the vaccine technology to Novavax’s new vaccine partners while protecting quality has begun in earnest.
Vaccine development and manufacturing is a complex process even when completed in house. Tech transfer and QC become even more complex when coordinating with a global development and manufacturing network.
Novavax’s Manufacturing, Science, and Technology (MS&T) and QC teams will play an enormous role in the successful and safe manufacture and distribution of the company’s COVID-19 vaccine candidate once approved by the FDA. A successful vaccine tech transfer involves the efficient transfer of knowledge and processes from one organization to another to ensure production efficiency, quality, and safety. While many of Novavax’s new partners have deep vaccine manufacturing and distribution experience, every technology has unique aspects to it that must be learned and incorporated into an established process to ensure success.
“Quality Assurance has the responsibility to ensure the systems and processes used to manufacture, test, and distribute drug product are efficient and effective,” shared Fred Shemer, Vice President, Quality Assurance. “QA is responsible and accountable to release drug product to the market and to ensure that every batch is pure, safe and effective.”
It is clear that the Novavax team has been pulling in the same direction and with the same passionate focus to achieve what it has since February 2020.
This is a testament to Novavax’s people and the strong, vibrant workplace culture it has built, evolved, and sustained over the years called SuperNova. The Novavax team is built on the foundation of hiring and developing extraordinary people with extraordinary purpose that value intellectual challenge, collaboration, risk-taking, and turning innovation into reality. Novavax’s SuperNovas are skilled, driven, and accomplished people that work in an environment that empowers them to do what they do best and to do what they love most.
The SuperNova mission has been crystallized and taken on new meaning during the fight against the coronavirus pandemic. Just as the company expanded its manufacturing and distribution network to meet the COVID-19 challenge, Novavax is actively searching for New SuperNovas to join its efforts to deliver its COVID-19 vaccine and other life-changing vaccines to patients across the globe.
Novavax is hosting a “SuperNova Virtual Recruiting Event” on December 9, 2020 (REGISTER HERE), in an effort to identify and hire new talent to add to its MS&T and QC teams. Key leaders from Novavax will participate in the event and will share insights into the company. Team members will also be available for Q&A at the conclusion of the event.
Participating Novavax team members participating include:
- John Kutney – Senior Director, Manufacturing
- Kate Malachowski – Associate Director, MS&T
- Jessica Suschak – Senior Manager, CMC Analytics
- Fred Shemer – Vice President, Quality Assurance
- Orinthal McIntyre – Senior Quality Assurance Manager
- Samantha Koziar – QA Training Specialist II
Novavax is seeking to hire for the following positions and others:
- Associate Director, Quality Assurance
- Sr Manager/Manager, QA
- QA Specialist IV, Operations
- Manager, Tech Transfer
- Tech Transfer Lead
- Tech Transfer Lead, Drug Substance Operation
- Director, MS&T
- MS&T Engineer
Join the Novavax team on December 9th, 2020, to learn more about these opportunities to become an essential part of the company’s ongoing, remarkable journey. This is a once-in-a-lifetime opportunity to make an indelible mark on public health and save lives.
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