LONDON – These are hardly times for a fanfare, but this month saw the unveiling of a new name in bioprocessing, following the formal closing of the $21.4 billion sale of GE Healthcare’s Life Sciences to Danaher Corp.

The business, now renamed Cytiva, has turnover of $3.3 billion, nearly 7,000 employees and operations in 40 countries. More than 75% of FDA-approved biologic drugs use its products in their manufacture.

It may look like leaving the embrace of one sprawling industrial conglomerate to fall into the arms of another, but the president of Cytiva, Emmanuel Ligner, said the business will operate at arm’s length from Danaher’s other companies.

“We are creating a standalone operating company, under the ownership of Danaher,” said Ligner. “It is a different size and scale, with more focus around life sciences and diagnostics,” he told BioWorld.

Cytiva was the name of a human heart cell line GE Healthcare sold for use in toxicology studies. It was seen as apt because it combines the first three letters of cyto – Greek for cell – and – iva, a Latin suffix that translates as “capable of.”

Emmanuel Ligner, president, Cytiva

“We were looking for a name that was reflective of what we do,” Ligner said.

New stablemates at Danaher include lab equipment supplier Beckman Coulter, nucleic acid manufacturer Integrate DNA Technologies, Leica Microsystems, manufacturer of scientific instruments, and the filtration, separation and purification specialist Pall Corp.

While the acquisition means Danaher now has an end-to-bioprocessing offering, synergies with others of the group’s businesses are not part of the story. “We are excited to work with companies in the same industry, and will cooperate to serve customers we have in common,” said Ligner.

GE Healthcare retained the radiopharmaceuticals unit. The sale of the rest of Life Sciences leaves the Chicago-based med tech with a $16.6 billion turnover business.

For GE as a whole, the sale is a “critical milestone” in the company’s corporate turnaround, said Lawrence Culp, CEO, when the deal completed at the start of the month. The net cash proceeds of $20 billion are certainly much needed to reduce the debt GE has accumulated over many years of costly acquisitions, with net debt standing at 4.2 times earnings at the start of 2020.

A former CEO of Danaher, Culp was brought in to rescue GE’s fortunes in late 2018. Alongside selling off assets, he set about streamlining the business through the application of Kaizen, the Japanese management philosophy of continuously improving processes. Culp also applied Kaizen at Danaher, where it is acknowledged to have improved the performance of the group’s companies.

Having picked up on Kaizen principles under Culp’s management at GE, Ligner said he is looking forward to continuing to apply them at Cytiva.

“Lean manufacturing was already a part of the GE culture, so there is a common culture and there will be continuity,” said Ligner. “It is something we think about constantly, about how to do better, and help customers go faster with process development.”

Ligner has been president of Cytiva since July 2017, after joining GE Healthcare in April 2008 when it acquired laboratory filtration specialist Whatman Group plc, where he was vice president of sales and marketing. Ligner is based in Amersham, U.K., but he said Cytiva will not have an official headquarters.

What the future holds

Process development and products and services for manufacturing monoclonal antibodies and recombinant protein drugs will continue to be the mainstay of Cytiva’s business.

However, Ligner said there will be a push to develop cell and gene therapy capabilities, a sector where GE Healthcare has made significant investments, and which Cytiva will continue to pursue.

“Gene and cell therapy is an area where we keenly invested over the last five years,” said Ligner. “It is fast growing and we are keen to contribute.”

While there are now FDA- and EMA-approved products, many of the cell and gene therapy products reaching the later stages of clinical development have origins in academic labs, and their production includes manual steps. Therapies coming from an academic research environment are likely to use materials approved for research only, and may be undefined and uncontrolled.

Yet at the same time, cell and gene therapies often are on an accelerated route to commercialization, in some cases going direct from smallish phase IIb studies to market. That leaves little time to conduct bridging studies and to develop a commercial bioprocess.

With autologous cell and gene therapies there are the additional demands of manufacturing a quality assured product from variable inputs, at the scale of one per batch.

Then there is the issue of getting the product back to the patient, with the clinical delivery of cell and gene therapies calling for all processing steps, including freezing, storage and thawing to be validated, monitored and recorded. There is a regulatory requirement to ensure high viability of cells on thawing, raising challenges of guaranteeing viability in the context of thawing in an operating theatre or a clinic.

As an example of how Cytiva’s technologies are helping to address those issues, Ligner referenced its cryopreservation products, originally developed by Asymptote Ltd., of Cambridge, U.K., a company GE Healthcare acquired in 2017.

Asymptote had received several grants from the U.K. innovation agency Innovate UK to develop equipment for delivering cryopreserved cells for clinical use. Cytiva’s VIA Thaw system, based on the Asymptote technology, enables the controlled thawing of cryopreserved cell therapies, overcoming the multiple inconsistent elements in standard water bath thawing, and providing a reproducible and traceable recovery system.

“There is more to be done. We will continue to invest, for example, in viral vector manufacturing. The tools are not so good at the moment, and the processes are not necessarily solid enough,” said Ligner.

One recent move to improve the situation is a collaboration with the Children’s Medical Hospital in Sydney, which specializes in treating inherited rare diseases and childhood cancers. The partners are working on improving purification technology for adeno-associated (AAV) viral vectors.

As another example, Cytiva is in the process of setting up a large-scale viral vector manufacturing facility at the University of Massachusetts Medical School, to provide AAV vectors for preclinical research.

At present, academic researchers face delays of 12 to 24 months to get supplies of vectors for testing in disease models, and the aim is to alleviate the bottlenecks in manufacturing that are holding back the initial stages of developing gene therapies.

Partnering for COVID-19

No single company can plug all the gaps in bringing cell and gene therapies to market, said Ligner. “We have to partner, to develop new tools and accelerate development.”

That philosophy is being applied in the race to develop vaccines and diagnostics for COVID-19. Ligner said the company has talked to Moderna Inc. and others that are in the early stages of developing vaccines “to understand what they are trying to achieve” and how Cytiva could help with process and assay development for phase I and phase II.

One of the lead vaccines is in development at the University of Queensland, Australia, with backing from the Coalition for Epidemic Preparedness Innovation. Cytiva is supporting manufacture of phase I supplies and working on scale-up planning for the manufacture of phase II material.

Rather than moving sequentially, things are being done in parallel. “You need to be agile and responsive,” Ligner said. “We have a team in place to support COVID-19 research. There is a long lead time for manufacturing.”

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