Bioreactor manufacturing facility
Cytiva opened a new facility for manufacturing Xcellerex XDR bioreactors in Shrewsbury, Massachusetts, US, in December 2020.
The new manufacturing facility has been developed as a part of the company’s five-year plan to expand its global manufacturing capacity with a total investment of $500m to tap the rising demand for its technologies and solutions and new market opportunities.
The Shrewsbury facility enabled the company to release the manufacturing capacity in the Westborough facility, Massachusetts, for the manufacturing of complementary single-use technologies. Cytiva aims to expand the Westborough facility’s capacity by the second quarter of 2021.
A technology investment agreement signed between Cytiva and the Biomedical Advanced Research and Development Authority (BARDA) in October 2020 benefitted the new manufacturing facility.
Cytiva plans to hire approximately 200 Massachusetts residents for the plant for various roles.
Cytiva’s new facility in Shrewsbury is an addition to the company’s global manufacturing and distribution network present across 13 sites in North America, Europe and Asia.
The 80,000ft2 facility is equipped with five production lines that operate 24 hours through five days a week, a new clean room and a research and development laboratory.
Automation has been increased at the facility to provide additional manufacturing capacity.
Xcellerex XDR is a single-use, cell culture bioreactor system with robust stirred tank efficiency of up to 2,000l in both cGMP (current good manufacturing practice) and non-cGMP environments.
XDR bioreactor platforms are available with operating volumes of 50l, 200l, 500l, 1,000l and 2,000l and can be operated in batch, fed-batch and perfusion bioreactor modes, depending on their development objectives.
The bioreactor vessel is made up of 304-grade stainless steel. The bioreactor bag assembly (XDA) is disposed of after the termination of culture, eliminating the costly and time-taking cleaning-in-place (CIP) and steam-in-place (SIP) functions.
Bioreactors offer versatile and scalable options for biopharmaceutical, vaccine and antibodies manufacturers. The systems deliver a seamless transition from process development to production scale, with the ease and cost-effectiveness of single-use technology.
XDR stirred tank bioreactor is proven and dependable, whether migrating from re-useable technology or opening a new facility.
The biotherapeutics sector is expected to witness double-digit growth by 2025. Approximately 85% of the biologics used in pre-commercial and clinical scale are manufactured using single-use technologies, according to BioPlan’s 2020 Report and Survey of Biopharmaceutical Manufacturing Capacity and Production.
Cytiva plans to more than double its single-use products’ manufacturing capacity by installing additional equipment and infrastructure at various sites.
Its partnership with Wego, a healthcare technology supplier in China, will enable it to triple its single-use capacity in the Asia-Pacific.
Formerly part of GE Healthcare Life Sciences, Cytiva is a global healthcare technologies and services provider with more than 7,000 associates in 40 countries dedicated to improving access to life-changing therapies that transform human health.
The company brings efficiency to research and manufacturing workflows, ensuring the development, production and distribution of ground-breaking medications to patients. More than 75% of the biological therapies approved by the US Food and Drug Administration (FDA) in 2019 depended on Cytiva’s manufacturing technologies.
The company also doubled its MabSelect and Capto chromatography product platforms’ manufacturing capacity through the facility modernisation programme at its site in Uppsala, Sweden.
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