A bill has been introduced into Congress to establish a competitive grant program to award money to manufacturers with the goal of establishing training centers and upping production capacity in order to provide more mRNA vaccines for the world.
The bill will permit the US Department of Health and Human Services to solicit interested companies with experience in mRNA manufacturing to identify chances to scale up production capacity.
‘Importantly, initial production could provide more mRNA COVID vaccines for the world,’ coronavirus response coordinator Jeffrey Zients said. ‘The goal of this program is to expand existing capacity by an additional billion doses per year, with production starting by the second half of 2022.’
In theory, the program would allow the US government to join forces with the brains of scientific researchers at the top pharmaceutical companies in America to help produce doses within six to nine months.
80% of Americans above the age of 12 have gotten at least one shot, and 10% of children have gotten their first shot, according to the White House.
‘We hope companies step up and act quickly to take us up on this opportunity to expand production of mRNA vaccines for the current pandemic and set us up to react quickly to any future pandemic threats,’ Zients said. ‘We know vaccinations are the best way to accelerate our path out of the pandemic.’
The US government would invest billions of dollars in this plan, dubbed HR 5993.
For years, paper-based processes and individual point solutions dominated the clinical research landscape, and patient participation in clinical trials was largely an in-person engagement. But when the COVID-19 pandemic took a stronghold, traditional clinical trial methods emerged as inadequate, putting clinical trials and the life sciences industry at a crossroads. Practically overnight, the industry had to rapidly shift to decentralized clinical trial methods, while maintaining data quality and regulatory compliance.
A 178-acre property on a stretch of the Pittsburgh riverfront used to be the home of an old steel mill that shut down in the 1990s. Now, it will get an upgrade from a $100 million grant out of the Richard King Mellon Foundation to turn it into a bio manufacturing facility run by the University of Pittsburgh.
The site, known as Hazelwood Green, is nearly half the size of Pittsburgh’s downtown and will be transformed into a home for cell and gene therapy. It will be dubbed Pitt BioForge, and offer research teams, commercial and research partners high-tech manufacturing capabilities, a wet lab and other spaces for innovation.
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Douglas Fambrough, Dicerna CEO (Dicerna via YouTube)
Early this year researchers at Novo Nordisk were beaming as they announced the first drug identified in their RNAi alliance with Dicerna was headed into the clinic. And now they’re coming back for the whole thing.
This morning the Copenhagen-based pharma giant put out word that it is buying Dicerna $DRNA — an RNAi pioneer that has had its up and downs over the years — for $3.3 billion. Novo is paying $38.25 a share — an 80% premium.
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Hovione executives Jean-Luc Herbeaux and Guy Villax stand in front of their booth at CPhI in Milan (Hovione PR)
Hovione is going global with its manufacturing expansion, from New Jersey all the way to Portugal.
The CDMO announced last week it would put $170 million into expansions in Portugal, Ireland and NJ, in an effort to increase its global capacity by 25%. The move follows an ongoing effort since 2016 to expand.
In a press release, COO Jean-Luc Herbeaux said:
These investments reinforce our integrated specialized offer globally, providing our clients with a line of sight for their projects. Focus is placed on facilitating and speeding up the drug development cycle and launch, by providing API manufacturing, Particle Engineering and Tableting services in each site. Our strategy continues to be to grow organically via investments in our existing sites, which are designed for purpose. This reduces the complexity associated with the growth journey and allows us to focus our management attention on what counts most, i.e. guaranteeing that our clients go to market with quality, safe and effective medicines for their patients.
A new cell and gene therapy testing facility in Philadelphia’s Navy Yard is officially opened, WuXi ATU announced Monday.
The new facility includes 140,000 square feet worth of laboratories, and will enhance the company’s contract testing, development and manufacturing organization business model by tripling the company’s previous capacity.
The move helps strengthen the existing testing capacity and capability, and combines the company’s powerful testing capabilities with its advanced therapies’ process development and manufacturing platforms, such as TESSA technology for AAV manufacturing and XLenti stable solutions for lentiviral manufacturing, it says in a press release.
The holding company of a South Korean vaccine maker is in the final talks to make an investment into a US gene therapy firm.
SK Biosciences is in the process of signing a deal with the Center for Breakthrough Medicines (CBM), a Philadelphia-based CDMO. If finalized, the deal will come eight months after SK’s takeover of the French gene and cell therapy company Yposkesi.
With this move, SK takes itself a step closer to establishing a value chain of synthetic and bio pharmaceuticals in the US, Europe and Asia by 2025, the company’s head of the investment center Lee Dong-hoon said in a presentation. The CBM is known for its production of plasmid DNA. With SK’s investment, it will expand manufacturing facility in the Cellicon Valley cell and gene therapy cluster by 699,654 square feet.
Gilead is going all in — hook, line and sinker — on its oncology alliance with Arcus. And they are going for broke.
The big biotech unveiled a deal that now delivers $725 million in opt-in payments covering the clinical development programs for Arcus, ranging from their closely watched anti-TIGIT programs for domvanalimab and AB308 to etrumadenant (the A2a/A2b adenosine receptor antagonist) and quemliclustat, the small molecule CD73 inhibitor. Gilead will also cover half of the development costs, handing Terry Rosen’s biotech a deal that gives them a clear cash runway to achieving all its goals in oncology.
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Thermo Fisher CEO Mark Casper
Another week, another win for the North Carolina biotech community.
This time, it’s Thermo Fisher Scientific, the Massachusetts-based contract giant, that recently announced it had plans to build a manufacturing plant. The winner is? Mebane, NC, a 15,000-person town 25 miles northwest of Durham.
The 375,000-square-foot plant at the Buckhorn Industrial Park will manufacture pipette tips for laboratory research and bioscience use. It’s a result from a $192.5 million contract with the Department of Defense that was announced back in September, in which the company pledged to increase its ability to support Covid-19 testing.
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Endo International is expanding its manufacturing capacity at a subsidiary to help out the US national stockpile, and it’s getting funding from the government to do so.
Par Sterile Products will expand the sterile fill-finish capacity at a Rochester, MI site to up the defense efforts against future pandemics. The company will establish a new line that’s fit with the capability of processing liquid or lyophilized products that require Biosafety Level 2 containment. It will also provided inspection and packaging capacity, and the government will fund the majority of the project — $90 million of the $120 million total cost.
https://endpts.com/congress-floats-new-grant-program-for-mrna-vaccine-makers-but-pharma-will-have-to-buy-in/
