Emmanuel Ligner, President and CEO, Cytiva

Cytiva, the former BioPharma business of GE Healthcare Life Sciences now owned by Danaher, said it will invest $500 million and hire 1,000 people over the next five years in an expansion of its global manufacturing capacity. The company’s acceleration is due to the global scramble to develop vaccines and drugs against COVID-19.

“We have to accelerate a few of our plans, because there’s some unforeseen demand which has come up with COVID,” Cytiva president and CEO Emmanuel Ligner told GEN.

“Our products are very well used in therapies and the majority of the vax which are currently in phase III,” Ligner said. “Which vaccine is going to win, which therapy is going to be approved or not, are a lot of unknowns, so it is very difficult to evaluate what is going to be the future demand. But we know that we will need a vaccine for sure, so we just have to be ready.”

Cytiva now works with more than 100 developers of COVID-19 drugs and vaccines. Among those that the company has disclosed are the University of Queensland in Australia, whose federal government agreed on September 6 to purchase 51 million doses of its COVID-19 vaccine UQ-CSL V451, which is being co-developed with Melbourne-based CSL. Takara Bio agreed in May to partner with Cytiva in manufacturing a plasmid vaccine designed to help protect people from COVID-19 by helping them generate the SARS-CoV-2 protein.

Cytiva is also working with Avacta to develop and evaluate lateral flow test strips designed to detect the SARS-COV-2 Spike protein, using Avacta’s Affirmer® reagents.

Ligner said Cytiva—which employs more than 7,000 people in some 40 countries—will carry out its expansion across its global product manufacturing and distribution network, which encompasses 13 sites across the U.S. and the rest of the Americas, as well as Asia, and Europe.

$3.3 Billion-a-Year Business

Cytiva provides technologies and services that help advance and accelerate the development and manufacture of therapeutics. The $3.3 billion-a-year business was re-branded and re-launched in April by Danaher after it completed its $21.4 billion purchase of the former GE Healthcare Life Sciences.

Cytiva’s businesses specialize in areas that include cell biology and protein research equipment for producing monoclonal antibodies and other biologics; process chromatography hardware and consumables; cell culture media; single-use technologies; development instrumentation; diagnostic tests; lateral flow assays; and consumables, and service.

At the time of the re-launch, Cytiva said it would expand its activity in cell and gene therapies, and carry out work with customers developing COVID-19 drugs, vaccines, and tests. Cytiva’s expansion will cover products, services, and processes used in developing monoclonal antibodies, as well as vaccines and fast-growing cell and gene therapies.

“We support all the modalities. We will continue to develop products across modalities,” Ligner said. “There’s no shift for us in terms of focus.”

He said the company plans to apply its expertise in monoclonal antibody production in building up its cell and gene therapy offerings, both on its own and through partnerships with academic institutions and commercial customers: “Nobody can do it alone.”

Tenfold increase

Cytiva is continuing a tenfold increase in powdered cell culture media production announced by GE Healthcare Life Sciences in May 2018. To that end, the company will build out new manufacturing lines and cleanroom space for cell culture media production in Logan, UT, where some 200 of the new positions will be created, and where additional shifts will be scheduled.

Also in the U.S., Cytiva in June completed an extensive renovation to its Fast Trak cGMP contract biomanufacturing and process development site in Marlborough, MA. The upgraded facility is 60,000 square feet and has bioprocessing capabilities ranging in scale from 10L to 2000L.

Thirteen miles southwest of Marlborough in Shrewsbury, MA, Cytiva recently leased a site where it plans to carry out manufacturing of bioreactors—an operation that the company is moving from a site about 7 miles southeast in Westborough, MA, where the company instead plans to expand its cleanroom for making single use technology bags and flow kits.

“We just signed the lease a couple of months ago,” Ligner said. “We are starting some activity to make the site up to the standard that we want, so there’s a bit of work to be done. But in a couple of months, that work will be over and we will start to produce there.”

Additional personnel and work shifts are also planned for the company’s sites in Singapore and Pasching, Austria.

In Uppsala, Sweden, a $350 million, five-year facility modernization program launched in 2017 by GE Healthcare is doubling the manufacturing capacity of Cytiva’s MabSelect and Capto chromatography product platforms. The modernization also includes new technologies to accommodate continuous manufacturing, extending the production capacity for its Sephadex resin, additional facilities for in-house manufacturing, and development of automation and digitalization infrastructure.

Cytiva’s cell processing efforts will be enhanced next year, when it is expected to begin operations at a 7,360-square-meter (79,222-square-foot) facility being built in Grens, Switzerland. The facility will manufacture single-use kits for its Sepax and Sefia cell processing systems.

Doubling Single Use Capacity

Cytiva also plans to double its capacity to manufacture single-use products for biomanufacturing, Ligner said, based on the expectation of increasing demand. The company plans to triple its single-use manufacturing capacity in the Asia-Pacific region through a collaboration with Wego, one of China’s largest healthcare technology suppliers. Wego already produces consumables for Cytiva’s customers in that region.

Single-use technologies are used to manufacture 85% of biologics now in pre-commercial and clinical manufacturing lines, Cytiva said, citing BioPlan’s 2020 Report and Survey of Biopharmaceutical Manufacturing Capacity and Production.

In addition to addressing demand within regions for Cytiva services, the company said its expansion also aims to bolster the security of supply by increasing overall global capacity in key product areas and applying “dual manufacturing” practices. These are designed to assure Cytiva customers that if one location encounters capacity constraints, the company can readily activate several back-up sites.

“It’s really across our portfolio, from the upstream to the downstream,” Ligner said.

To support the expansion, Cytiva has begun hiring 1,000 people worldwide. Approximately half that number will be hired in the U.S., while the rest will be hired in Austria, China, Singapore, Sweden, and Switzerland.

“There’s a broad range of jobs, from technicians to engineers to managers,” Ligner said. “We are recruiting, and we’ve been recruiting, and we will continue to recruit because we need a strong supply chain to support the demand that we are foreseeing for the future.”

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