The Expanding Landscape of Commercial Single-Use Bioreactors

Chekunov Alexandr/Stock.Adobe.com

The continued adoption of single-use bioreactors in the biopharmaceutical industry is growing, with several companies making the move to expand implementation of commercial-scale single-use bioreactors. WuXi Biologics, a contract development and manufacturing organization (CDMO) and part of WuXi AppTech, has announced a slew of investments showing its build-up of single-use bioreactor capacity. AGC Biologics, a full-service provider, and ABEC, a contract manufacturer, have also announcement investments in expanding their manufacturing capacities.

Commercial expansion

WuXi Biologics, a CDMO and part of WuXi AppTech, has been active in expanding its bioreactor capacity with several investments over the course of the past year. The company has been making multi-million-dollar investments into implementing these expansions.

The largest of these recent investments is a €325 million (US$370 million) investment announced on April 30, 2018 (1). The company is using the investment to build a new biomanufacturing facility in Mullagharlin, Dundalk, County Louth, Ireland. The new facility will use multiple single-use bioreactors for commercial biomanufacturing and is designed to be able to run continuous bioprocessing. A total of 48,000-L fed-batch and 6000-L perfusion bioreactor capacity will be installed.

The Ireland facility marks the first manufacturing site that WuXi will have outside of China. The project is expected to create more than 400 skilled jobs over a five-year span and add approximately 700 construction jobs. Following the Ireland facility announcement, WuXi reported a S$80 million (US$60 million) investment in May 2018 to establish a biologics manufacturing facility in Singapore (2), its tenth global drug substance manufacturing facility. The Singapore site represents the company’s second site outside of China and its first in Asia that is outside of China.

This facility will house single-use bioreactors with a total of approximately 4500-L bioreactor capacity that will be installed with two 2000-L traditional fed-batch and one 500-L perfusion-based continuous processing bioreactors. The facility will handle both clinical and small-volume commercial production. The site will also house an early-stage bioprocess development laboratory. The investment will provide approximately 150 jobs. 

In the United States, WuXi is also investing $60 million to establish a biologics clinical and commercial manufacturing facility in Worcester, MA. The company announced this investment in June 2018 (3). This US site will be the company’s eleventh global drug substance manufacturing facility and its first in the US.

The Worcester facility will also house single-use bioreactors and will be designed to run continuous bioprocessing. The company plans to install a total of approximately 4500 L of bioreactor capacity using two 2000-L traditional fed-batch bioreactors and one 500-L perfusion-based continuous process bioreactor.

Similar to the Singapore facility, the Worcestor facility will handle both clinical and small-volume commercial production, and the company will include an early-stage bioprocess development lab as well. The site will provide positions for approximately 150 employees.

Capacity buildup

These 2018 announced investments follow a larger earlier investment the company made in April 2015. At that time, WuXi announced a $150-million investment to build a new 30,000-L cGMP biologics manufacturing facility in Wuxi, China. That facility started up operations in early December 2017 and is now fully operational (4).

The Wuxi facility houses two 1000-L disposable perfusion-based bioreactors and 14 2000-L disposable fed-batch cell culture-based bioreactors. The 500,000-ft2 facility quintuples the company’s existing manufacturing capability and supports the biologics commercial manufacturing pipeline coming from the company’s global partners.

The company also announced in March 2018 that it plans to install 4000-L custom single run (CSR) disposable bioreactors supplied aby ABEC, a provider of integrated process solutions and biopharmaceutical manufacturing services, at the new Wuxi facility (5).

This 4000-L CSR bioreactor is the largest single-use bioreactor size available in the industry today and is potentially the largest design in conventional disposable bioreactors, according to WuXi. The system can be fully customized for different products, the company reports. The company’s scale-out strategy involves using multiple 4000-L CSRs for commercial manufacturing, which would enable production up to a scale of 24,000 L, comparable to stainless-steel bioreactors. 

In a similar move to grow its manufacturing capacity, AGC Biologics, a CDMO, is adding a 2000-L single-use bioreactor to its Berkeley, CA, facility to support its biologics capacity. The company announced the addition in March 2018 (6). The Berkeley facility is one of six facilities that AGC runs worldwide. The company has tripled capacity at its Berkeley site over the past three years. The facility uses both single-use and stainless-steel bioreactors for cell culture manufacturing in scales from 100 L–3000 L. The facility provides cell bank manufacturing and storage.

AGC Biologics is a recent integration of Asahi Glass Company (AGC) Bioscience, a glass and chemical producer under AGC, Biomeva GmbH, a contract manufacturing organization, and CMC Biologics, a contract biologics manufacturer. AGC Biologics was formed in January 2018 (7). 

Launch of the 4000-L bioreactor

The 4000-L-scale single-use bioreactor was launched by ABEC in July 2017 (8). The company noted that it is the only supplier that today can provide single-use bioreactors with capacities greater than 2000 L. 

Benefits of the 4000-L single-use bioreactor include a reduction in capital, facility, and disposables cost by doubling cell-culture capacity in approximately the same floor space. In addition, the capacity of the vessel can lead to a reduction by half of the number of systems and disposable containers needed, which in turn can mean a reduced-size facility, according to ABEC. 

Performance of the 4000-L bioreactor is comparable to that of stainless-steel systems, which figure prominently in the company’s CSR product line. Other features of the line include large production volumes, seamless process transfer and scale-up, rapid container loading, and a non-proprietary supply chain. 

References

1. WuXi Biologics, “WuXi Biologics to Invest €325 Million to Build Largest Biomanufacturing Facility Using Single-Use Bioreactors in Ireland,” Press Release, April 30, 2018.
2. WuXi Biologics, “WuXi Biologics to Invest S$80 Million to Establish a Biologics Manufacturing Facility in Singapore,” Press Release, May 22, 2018.
3. WuXi Biologics, “WuXi Biologics to Invest $60 Million to Establish a Biologics Production Facility in the United States,” Press Release, Jun 11, 2108.
4. WuXi Biologics, “WuXi Biologics Initiated CGMP Manufacturing in the World’s Largest Biologics Manufacturing Facility Using Single-Use Bioreactors,” Press Release, Dec. 6, 2017.
5. WuXi Biologics, “WuXi Biologics to Install Industry’s Largest Single-Use Bioreactor from ABEC at Its New Commercial Manufacturing Facility,” Press Release, March 20, 2018.
6. AGC Biologics, “AGC Biologics Expands Capacity at Berkeley, California Facility,” Press Release, March 6, 2018.
7. AGC Biologics, “AGC Bioscience, Biomeva, and CMC Biologics to Provide Services Under the Brand AGC Biologics,” Press Release, Jan. 8, 2018.
8. ABEC, “ABEC Sets a New Benchmark in Single Use Bioreactor Capacity,” Press Release, July 10, 2017. 

Article Details

BioPharm International
Vol. 32, No. 3 
March 2019 
Pages: 20–21

Citation

When referring to this article, please cite it as F. Mirasol, “The Expanding Landscape of Commercial Single-Use Bioreactors,"BioPharm International 32 (3) 2019.