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White House preps to pump bil­lions in­to mR­NA vac­cine man­u­fac­tur­ing ca­pac­i­ty — but Mod­er­na and Pfiz­er will have to buy in

The White House released early details this week on its plan to pump billions of new dollars in mRNA vaccine manufacturing to increase the number of doses abroad and prepare for the next pandemic too.

“Importantly, initial production could provide more mRNA COVID vaccines for the world,” coronavirus response coordinator Jeffrey Zients said Thursday at a media briefing. “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.”

WuXi of­fi­cial­ly opens cell and gene ther­a­py site in Philly; An­oth­er mas­sive man­u­fac­tur­ing site comes to NC

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.

South Ko­re­an drug­mak­er SK looks to take over Philly CD­MO's op­er­a­tions

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.

Thermo Fisher CEO Mark Casper

Ther­mo Fish­er re­veals new home for its planned NC site with plans to up pipette man­u­fac­tur­ing

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 part­ners up with US gov­ern­ment on $120M in­fu­sion in­to the na­tion­al stock­pile

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.

A cell containing smallpox viruses, as captured by transmission electron microscopy

UP­DATE: Re­ports of small­pox-la­beled vials at Mer­ck plant con­tained 'no trace' of virus

Smallpox was declared eradicated  in 1980 by the World Health Organization, after an effort to vaccinate the globe. But several vials labeled as the disease were found at a Pennsylvania vaccine research facility belonging to Merck, when a laboratory worker was cleaning out a freezer.

The CDC released a statement Thursday stating that the vials contained no trace of the virus, but rather, the virus used in the smallpox vaccine, and not variola, the virus that causes smallpox.

As $2B 'su­per­plan­t' moves ahead, Sam­sung Bi­o­log­ics touts plans for fifth fa­cil­i­ty at South Ko­re­an site

Samsung Biologics already has three plants in Songdo, Incheon, South Korea, and another on the way — and it just gained approval to build a fifth.

The company will build a production site for genetic medicines, The Korea Herald reported, after the Incheon Free Economic Zone Authority gave the OK to a purchase of 32,808 square feet in the city. That site will be completed by 2023, if all goes according to plan, and Samsung will spend $259 million on its construction.

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Fu­ji­film boosts man­u­fac­tur­ing ca­pac­i­ty along­side R&D; Bax­ter In­ter­na­tion­al will in­vest $100M in Bio­Phar­ma So­lu­tions

Fujifilm Irvine Scientific is expanding an R&D center in California, and it’s boosting its manufacturing along with it.

The company announced Wednesday that it would expand its Armstrong R&D Center of Excellence at headquarters in Santa Ana, in order to commit to the advancement of discovery research, bioproduction, and cell and gene therapy among other things. But as its experienced a significant amount of revenue increase in the past year, and boasting of new manufacturing capabilities in Europe, the expansion will help aid those efforts.

Jonathan Yongwan Jo, List Bio CEO

List Bio to join In­di­ana biotech com­mu­ni­ty with $125M CMO in­vest­ment, 210 new hires

An expansion is coming to the Fishers Life Science and Innovation Park, and with it, plans to hire another 210 employees by the end of 2023.

List Biotherapeutics will pump $125 million into the project, establishing a 110,000-square-foot CMO facility across 15 acres in the park. There will be both lab and office space, and new employees will be hired for roles in biologics manufacturing and quality and regulatory compliance.

Wel­come to CPhI week: The drug man­u­fac­tur­ing in­dus­try's pre­mier con­fer­ence kicks off with the winds of change blow­ing

Welcome to CPhI week!

Tuesday marked the opening of this year’s CPhI Global conference in Milan, Italy, in what marks its return to an onsite event for the first time since 2019.

In many ways, this year’s CPhI is different for us here at Endpoints News. We aren’t on site — as we certainly plan to be next year — so we can’t give you the inside scoop you can expect in the future. However, our team has been closely following the biggest trends from the past year and are staying abreast of what CPhI’s stable of experts are saying about the future of the industry.