The Serum Institute – which is the world's largest vaccine manufacturer by number of doses – has already made a agreement to manufacture around 1 billion doses of Novavax’s vaccine candidate NVX-CoV2373 next year (representing around half of Novavax’s planned total capacity of 2 billion doses annually).
Novavax’s COVID-19 vaccine candidate is engineered from the genetic sequence of SARS‑CoV‑2. It uses Novavax’s recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein, and contains Novavax’s saponin-based Matrix-M adjuvant. The vaccine entered into Phase 3 trials in the UK last week.
Serum Institute is due to advance a global supply of NVX-CoV2373 throughout India and low- and middle-income countries.
ABEC bioreactors: largest in industry
Serum Institute’s new vaccine production facility in Pune - inaugurated in September last year - will become the largest single-use bioreactor-based vaccine manufacturing line in the world.
ABEC - based in Bethlehem, Pennsylvania - champions its 4,000L custom single run (CSR) single-use bioreactors as larger than others in the industry by a factor of two. This means the Serum Institute will be able to double productivity per unit floorspace and achieve the lowest possible cost per dose.
ABEC has been on a mission over the last few years to increase the size of its bioreactors; and now offers bioreactors in any volume up to 6,000L. Alongside the space savings and cost savings, they also offer the advantage of speed, says the company. And all these factors become more and more important for COVID-19 vaccine production.
"ABEC’s large-scale single-use bioreactors enable customers to realize the benefits of single use processing such as multi-product flexibility, faster batch turnaround, and faster time to market, without sacrificing performance and productivity," the company told BioPharma-Reporter.
"Customers can double or triple cell culture capacity per unit floorspace, resulting in significant savings in capital, facility, and disposables cost.
"We're proud to be part of Serum Institute's urgent work to supply the Novavax COVID-19 vaccine," said Scott Pickering, ABEC President & CEO.
"This critical project exemplifies and is enabled by all of the core values that ABEC is built on: integrity, credibility, knowledge leadership, flexibility & long-term commitment."
"These systems also provide performance equivalent to traditional stainless steel systems so that customers can achieve the highest possible product yields.
"These capabilities are ideal for COVID-19 since billions of doses are needed at a reasonable cost per dose."
ABEC is manufacturing the single-use bioreactors and disposable containers for Serum at its facilities in the US and Ireland; and says it will deliver to Pune in time for the company to begin production of the vaccine in early 2021.
The company is also supporting other COVID-19 vaccine and therapeutic efforts with single-use and stainless steel systems as well as site services.
This includes CSR cell culture bioreactors up to 4,000L and CSR microbial fermenters up to 1,000L (also the largest available in the industry).