Emergent has received $628 million to support vaccine production; Novavax buys Czech Republic-based Praha Vaccines; Vaxart contracts Kindred Biosciences. Just another week in the fight against COVID-19.
Emergent Biosolutions is working on several projects to support the development of COVID-19 vaccines but has been buoyed by a US government task order of $628 million to support rapid domestic production through 2021.
The task order forms part of a contract with the¬†Biomedical Advanced Research and Development Authority¬†(BARDA), part of the¬†US Department of Health & Human Services¬†(HHS) and falls under the government‚Äôs Warp Speed Program aimed at paving the way for innovators to advance COVID-19 programs.
Warp Speed is a public-private program to expedite vaccines against the novel coronavirus (SARS-CoV-2). The White House will work with several pharmaceutical companies ‚Äď currently Moderna, Johnson & Johnson, Merck & Co., AstraZeneca (and its partner Oxford University), and Pfizer (and its partner BioNTech) ‚Äď to speed their candidates through the clinic.
For Emergent, the award will be used to bolster capacity for drug substance manufacturing at the company‚Äôs Baltimore Bayview facility and for drug product manufacturing at the Baltimore Camden and Rockville locations. The task order also includes an investment of approximately $85.5 million for the rapid expansion of Emergent‚Äôs viral and non-viral CDMO drug product fill/finish capacity at the two facilities.
Novavax Czechs in
Emergent has already inked contracts to manufacture a vaccine candidate for J&J, but the firm has also entered a contract to make Novavax‚Äôs COVID-19 vaccine candidate NVX‚ÄĎCoV2373, which leads us neatly to the next piece of capacity news.
Novavax has acquired Czech Republic-based firm Praha Vaccines for roughly $167 million. The acquisition gives Novavax a 150,000 square-foot vaccine and biologics manufacturing facility in Bohumil, Czech Republic, which will be used to support the aforementioned COVID-19 vaccine candidate.
Meanwhile, Novavax has inked a deal with CDMO AGC Biologics for the large-scale GMP production of Matrix-M, the adjuvant component of its coronavirus vaccine candidate.
Regular readers will remember Novavax handing control of two facilities in Rockville and Gaithersburg, Maryland to Catalent‚Äôs Paragon unit last July, though the firm did not respond when asked whether this was regretful 11 months on in light of the need for COVID-19 capacity.
Vaxart and Kindred
Oral vaccine developer Vaxart has contracted Kindred Biosciences to make its COVID-19 candidate from its biological development and cGMP manufacturing facility in Burlingame, California.
The contract development and manufacturing (CDMO) will produce the candidate vaccine bulk drug substance and provide it to Vaxart to be formulated into a vaccine tablet to be taken by mouth instead of by needle injection. Clinical trials of the proposed product are expected to begin in the second half of 2020.
‚ÄúWe believe our novel approach utilizing a room temperature-stable tablet offers important logistical advantages in widespread oral vaccination, and that KindredBio with its state-of-the-art manufacturing plants is an ideal partner to realize our vision,‚ÄĚ Vaxart‚Äôs CEO Wouter Latour said in a statement.
Baylor and MilliporeSigma
Baylor College of Medicine has extended its collaboration with MilliporeSigma to advance a manufacturing platform to accelerate the transition of its candidate into Phase I clinical trials.
‚ÄúThere are no standard manufacturing templates or processes due to the complexity and diversity of vaccine modalities, which makes production a challenge for every organization racing to develop a safe and effective Covid-19 vaccine,‚ÄĚ the firms said in a statement.
‚ÄúUsing key learnings from their ongoing collaboration on a schistosomiasis vaccine, MilliporeSigma, along with researchers at Baylor College of Medicine and the Texas Children’s Hospital Center for Vaccine Development, is optimizing the production process to advance two Covid-19 vaccine candidates, including the CoV RBD219-N1 vaccine candidate expected to enter clinical trials later this year.
‚ÄúMilliporeSigma will help to accelerate their suitability for large-scale manufacturing. This collaboration will focus on improvements to production efficiency, yield, robustness, scalability and costs.‚ÄĚ