ABEC will supply six 4,000 L single-use bioreactors to the Serum Institute of India and says such large-scale systems can produce billions of doses of potential COVID-19 vaccines at reasonable costs.

The six Custom Single Run (CSR) bioreactors will be delivered to the Serum Institute’s site in Pune, India and will be used to manufacture Phase II COVID-19 vaccine NVX‑CoV2373. The candidate has been developed by Novavax, which last month inked a deal with the Indian vaccine maker to produce more than one billion doses of the proposed prophylactic.

Traditionally, vaccines intended for large patient populations have been made in stainless-steel systems. Single-use bioreactors generally have an upper limit of 2,000 L and historically would not be deemed cost effective to make pandemic-levels of a vaccine.

ABEC’s 4,000 L CSR single-use bioreactor

However, ABEC has always looked beyond the 2,000 L limit of single-use – it launched a 4,300 L bioreactor (with 3,500 L of working volume) in 2015, a 4,900 L system with a 4,000 L working volume in 2017, and a 7,500 L bioreactor with working volumes up to 6,000 L last year – and told us such systems are ideal to take on the challenges involved in COVID-19 vaccine manufacture.

“Customers can double or triple cell culture capacity per unit floorspace, resulting in significant savings in capital, facility, and disposables cost. These systems also provide performance equivalent to traditional stainless-steel systems so that customers can achieve the highest possible product yields,” said spokeswoman Susan Cooper-Curcio. “These capabilities are ideal for COVID-19 since billions of doses are needed at a reasonable cost per dose.”

Beyond Novavax and the Serum Institute, ABEC’s single-use systems (SUS) are being used to support multiple COVID-19 vaccine and therapeutic efforts, she added. While other projects remain confidential, a 4,000 L system is installed at Emergent Biosolution’s site in Bayview, Maryland where several COVID-19 manufacturing projects are underway.

Meanwhile, general interest in single-use systems in vaccine production is on the rise. “We were seeing vaccine production moving into single use well before COVID-19.  It may be accelerating somewhat since COVID-19 but we do not view COVID-19 as a turning point.”

Supply and demand

With so much capacity being obtained to make COVID-19 vaccines and products, there has been some concern biopharma faces delays obtaining single-use systems.

But for ABEC, Cooper-Curcio allayed such fears, telling us the firm has complete, in-house manufacturing of both single-use and stainless steel products, including equipment, disposable containers, and vessels.

“We have the largest equipment manufacturing capacity in the industry (300,000 sq. ft.) as well as two ISO-7 cleanrooms on two continents for disposables manufacturing. Unlike many others, we do not outsource manufacturing, and therefore have complete control of our capacity, quality, and supply chains.”