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Cytiva Plans $500M Expansion, 1,000 New Hires Worldwide

Cytiva Plans $500M Expansion, 1,000 New Hires Worldwide

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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.”

The post Cytiva Plans $500M Expansion, 1,000 New Hires Worldwide appeared first on GEN - Genetic Engineering and Biotechnology News.

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Four burning questions about the future of the $16.5B Novo-Catalent deal

To build or to buy? That’s a classic question for pharma boardrooms, and Novo Nordisk is going with both.
Beyond spending billions of dollars to expand…

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To build or to buy? That’s a classic question for pharma boardrooms, and Novo Nordisk is going with both.

Beyond spending billions of dollars to expand its own production capacity for its weight loss drugs, the Danish drugmaker said Monday it will pay $11 billion to acquire three manufacturing plants from Catalent. It’s part of a broader $16.5 billion deal with Novo Holdings, the investment arm of the pharma’s parent group, which agreed to acquire the contract manufacturer and take it private.

It’s a big deal for all parties, with potential ripple effects across the biotech ecosystem. Here’s a look at some of the most pressing questions to watch after Monday’s announcement.

Why did Novo do this?

Novo Holdings isn’t the most obvious buyer for Catalent, particularly after last year’s on-and-off M&A interest from the serial acquirer Danaher. But the deal could benefit both Novo Holdings and Novo Nordisk.

Novo Nordisk’s biggest challenge has been simply making enough of the weight loss drug Wegovy and diabetes therapy Ozempic. On last week’s earnings call, Novo Nordisk CEO Lars Fruergaard Jørgensen said the company isn’t constrained by capital in its efforts to boost manufacturing. Rather, the main challenge is the limited amount of capabilities out there, he said.

“Most pharmaceutical companies in the world would be shopping among the same manufacturers,” he said. “There’s not an unlimited amount of machinery and people to build it.”

While Novo was already one of Catalent’s major customers, the manufacturer has been hamstrung by its own balance sheet. With roughly $5 billion in debt on its books, it’s had to juggle paying down debt with sufficiently investing in its facilities. That’s been particularly challenging in keeping pace with soaring demand for GLP-1 drugs.

Novo, on the other hand, has the balance sheet to funnel as much money as needed into the plants in Italy, Belgium, and Indiana. It’s also struggled to make enough of its popular GLP-1 drugs to meet their soaring demand, with documented shortages of both Ozempic and Wegovy.

The impact won’t be immediate. The parties expect the deal to close near the end of 2024. Novo Nordisk said it expects the three new sites to “gradually increase Novo Nordisk’s filling capacity from 2026 and onwards.”

As for the rest of Catalent — nearly 50 other sites employing thousands of workers — Novo Holdings will take control. The group previously acquired Altasciences in 2021 and Ritedose in 2022, so the Catalent deal builds on a core investing interest in biopharma services, Novo Holdings CEO Kasim Kutay told Endpoints News.

Kasim Kutay

When asked about possible site closures or layoffs, Kutay said the team hasn’t thought about that.

“That’s not our track record. Our track record is to invest in quality businesses and help them grow,” he said. “There’s always stuff to do with any asset you own, but we haven’t bought this company to do some of the stuff you’re talking about.”

What does it mean for Catalent’s customers? 

Until the deal closes, Catalent will operate as a standalone business. After it closes, Novo Nordisk said it will honor its customer obligations at the three sites, a spokesperson said. But they didn’t answer a question about what happens when those contracts expire.

The wrinkle is the long-term future of the three plants that Novo Nordisk is paying for. Those sites don’t exclusively pump out Wegovy, but that could be the logical long-term aim for the Danish drugmaker.

The ideal scenario is that pricing and timelines remain the same for customers, said Nicole Paulk, CEO of the gene therapy startup Siren Biotechnology.

Nicole Paulk

“The name of the group that you’re going to send your check to is now going to be Novo Holdings instead of Catalent, but otherwise everything remains the same,” Paulk told Endpoints. “That’s the best-case scenario.”

In a worst case, Paulk said she feared the new owners could wind up closing sites or laying off Catalent groups. That could create some uncertainty for customers looking for a long-term manufacturing partner.

Are shareholders and regulators happy? 

The pandemic was a wild ride for Catalent’s stock, with shares surging from about $40 to $140 and then crashing back to earth. The $63.50 share price for the takeover is a happy ending depending on the investor.

On that point, the investing giant Elliott Investment Management is satisfied. Marc Steinberg, a partner at Elliott, called the agreement “an outstanding outcome” that “clearly maximizes value for Catalent stockholders” in a statement.

Elliott helped kick off a strategic review last August that culminated in the sale agreement. Compared to Catalent’s stock price before that review started, the deal pays a nearly 40% premium.

Alessandro Maselli

But this is hardly a victory lap for CEO Alessandro Maselli, who took over in July 2022 when Catalent’s stock price was north of $100. Novo’s takeover is a tacit acknowledgment that Maselli could never fully right the ship, as operational problems plagued the company throughout 2023 while it was limited by its debt.

Additional regulatory filings in the next few weeks could give insight into just how competitive the sale process was. William Blair analysts said they don’t expect a competing bidder “given the organic investments already being pursued at other leading CDMOs and the breadth and scale of Catalent’s operations.”

The Blair analysts also noted the companies likely “expect to spend some time educating relevant government agencies” about the deal, given the lengthy closing timeline. Given Novo Nordisk’s ascent — it’s now one of Europe’s most valuable companies — paired with the limited number of large contract manufacturers, antitrust regulators could be interested in taking a close look.

Are Catalent’s problems finally a thing of the past?

Catalent ran into a mix of financial and operational problems over the past year that played no small part in attracting the interest of an activist like Elliott.

Now with a deal in place, how quickly can Novo rectify those problems? Some of the challenges were driven by the demands of being a publicly traded company, like failing to meet investors’ revenue expectations or even filing earnings reports on time.

But Catalent also struggled with its business at times, with a range of manufacturing delays, inspection reports and occasionally writing down acquisitions that didn’t pan out. Novo’s deep pockets will go a long way to a turnaround, but only the future will tell if all these issues are fixed.

Kutay said his team is excited by the opportunity and was satisfied with the due diligence it did on the company.

“We believe we’re buying a strong company with a good management team and good prospects,” Kutay said. “If that wasn’t the case, I don’t think we’d be here.”

Amber Tong and Reynald Castañeda contributed reporting.

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Petrina Kamya, Ph.D., Head of AI Platforms at Insilico Medicine, presents at BIO CEO & Investor Conference

Petrina Kamya, PhD, Head of AI Platforms and President of Insilico Medicine Canada, will present at the BIO CEO & Investor Conference happening Feb….

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Petrina Kamya, PhD, Head of AI Platforms and President of Insilico Medicine Canada, will present at the BIO CEO & Investor Conference happening Feb. 26-27 at the New York Marriott Marquis in New York City. Dr. Kamya will speak as part of the panel “AI within Biopharma: Separating Value from Hype,” on Feb. 27, 1pm ET along with Michael Nally, CEO of Generate: Biomedicines and Liz Schwarzbach, PhD, CBO of BigHat Biosciences.

Credit: Insilico Medicine

Petrina Kamya, PhD, Head of AI Platforms and President of Insilico Medicine Canada, will present at the BIO CEO & Investor Conference happening Feb. 26-27 at the New York Marriott Marquis in New York City. Dr. Kamya will speak as part of the panel “AI within Biopharma: Separating Value from Hype,” on Feb. 27, 1pm ET along with Michael Nally, CEO of Generate: Biomedicines and Liz Schwarzbach, PhD, CBO of BigHat Biosciences.

The session will look at how the latest artificial intelligence (AI) tools – including generative AI and large language models – are currently being used to advance the discovery and design of new drugs, and which technologies are still in development. 

The BIO CEO & Investor Conference brings together over 1,000 attendees and more than 700 companies across industry and institutional investment to discuss the future investment landscape of biotechnology. Sessions focus on topics such as therapeutic advancements, market outlook, and policy priorities.

Insilico Medicine is a leading, clinical stage AI-driven drug discovery company that has raised over $400m in investments since it was founded in 2014. Dr. Kamya leads the development of the Company’s end-to-end generative AI platform, Pharma.AI from Insilico’s AI R&D Center in Montreal. Using modern machine learning techniques in the context of chemistry and biology, the platform has driven the discovery and design of 30+ new therapies, with five in clinical stages – for cancer, fibrosis, inflammatory bowel disease (IBD), and COVID-19. The Company’s lead drug, for the chronic, rare lung condition idiopathic pulmonary fibrosis, is the first AI-designed drug for an AI-discovered target to reach Phase II clinical trials with patients. Nine of the top 20 pharmaceutical companies have used Insilico’s AI platform to advance their programs, and the Company has a number of major strategic licensing deals around its AI-designed therapeutic assets, including with Sanofi, Exelixis and Menarini. 

 

About Insilico Medicine

Insilico Medicine, a global clinical stage biotechnology company powered by generative AI, is connecting biology, chemistry, and clinical trials analysis using next-generation AI systems. The company has developed AI platforms that utilize deep generative models, reinforcement learning, transformers, and other modern machine learning techniques for novel target discovery and the generation of novel molecular structures with desired properties. Insilico Medicine is developing breakthrough solutions to discover and develop innovative drugs for cancer, fibrosis, immunity, central nervous system diseases, infectious diseases, autoimmune diseases, and aging-related diseases. www.insilico.com 


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Another country is getting ready to launch a visa for digital nomads

Early reports are saying Japan will soon have a digital nomad visa for high-earning foreigners.

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Over the last decade, the explosion of remote work that came as a result of improved technology and the pandemic has allowed an increasing number of people to become digital nomads. 

When looked at more broadly as anyone not required to come into a fixed office but instead moves between different locations such as the home and the coffee shop, the latest estimate shows that there were more than 35 million such workers in the world by the end of 2023 while over half of those come from the United States.

Related: There is a new list of cities that are best for digital nomads

While remote work has also allowed many to move to cheaper places and travel around the world while still bringing in income, working outside of one's home country requires either dual citizenship or work authorization — the global shift toward remote work has pushed many countries to launch specific digital nomad visas to boost their economies and bring in new residents.

Japan is a very popular destination for U.S. tourists. 

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This popular vacation destination will soon have a nomad visa

Spain, Portugal, Indonesia, Malaysia, Costa Rica, Brazil, Latvia and Malta are some of the countries currently offering specific visas for foreigners who want to live there while bringing in income from abroad.

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With the exception of a few, Asian countries generally have stricter immigration laws and were much slower to launch these types of visas that some of the countries with weaker economies had as far back as 2015. As first reported by the Japan Times, the country's Immigration Services Agency ended up making the leap toward a visa for those who can earn more than ¥10 million ($68,300 USD) with income from another country.

The Japanese government has not yet worked out the specifics of how long the visa will be valid for or how much it will cost — public comment on the proposal is being accepted throughout next week. 

That said, early reports say the visa will be shorter than the typical digital nomad option that allows foreigners to live in a country for several years. The visa will reportedly be valid for six months or slightly longer but still no more than a year — along with the ability to work, this allows some to stay beyond the 90-day tourist period typically afforded to those from countries with visa-free agreements.

'Not be given a residence card of residence certificate'

While one will be able to reapply for the visa after the time runs out, this can only be done by exiting the country and being away for six months before coming back again — becoming a permanent resident on the pathway to citizenship is an entirely different process with much more strict requirements.

"Those living in Japan with the digital nomad visa will not be given a residence card or a residence certificate, which provide access to certain government benefits," reports the news outlet. "The visa cannot be renewed and must be reapplied for, with this only possible six months after leaving the countr

The visa will reportedly start in March and also allow holders to bring their spouses and families with them. To start using the visa, holders will also need to purchase private health insurance from their home country while taxes on any money one earns will also need to be paid through one's home country.

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