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In an ef­fort to safe­ly de­liv­er mR­NA, Stan­ford Uni­ver­si­ty teams up with Ger­man biotech Evonik

Delivering mRNA effectively and safely into the cell is one of the toughest challenges for expanding the use of the therapeutics that have taken off in popularity as of late. A deal between Germany-based specialty chemicals company Evonik and Stanford University will help develop a polymer-based delivery system for Evonik to license and commercialize.

The company will work with university scientists to scale up the synthesis and formulation to develop organ selective delivery based on a synthetic polymer through a system dubbed as CART that was developed by Stanford professors Robert Waymouth, Paul Wender and Ronald Levy.

Stéphane Bancel, Getty

Covid-19 man­u­fac­tur­ing roundup: As the US gov­ern­ment bags an­oth­er 100M dos­es of Mod­er­na shot, the biotech is chip­ping in on UAE roll­out

President Joe Biden’s administration has ordered another round of shots.

Moderna and the US government have reached a deal that will provide the company with another 200 million doses of its Covid-19 vaccine, and include the option to purchase other candidates from the company’s pipeline, Moderna announced Wednesday. The agreement brings the total number of Moderna shots to 500 million. Another 110 million will be delivered in Q4 of 2021 and 90 million are expected in Q1 of 2021.

In a move to boost its nat­ur­al killer can­di­dates, Sen­ti Bio will build out its own San Fran­cis­co man­u­fac­tur­ing fa­cil­i­ty

Silicon Valley synthetic biology player and Roche collaborator Senti Bio has been hush-hush about much of its science since it was founded in 2016, but the company made noise Tuesday when it announced it signed a lease agreement to build out a commercial-scale manufacturing facility in Alameda, CA.

The 92,000 square-foot facility will be built with the goal of providing clinical- and commercial-scale manufacturing for off-the-shelf CAR natural killer cell candidates. The site will support clinical trials for SENTI-202 for acute myeloid leukemia and SENTI-301 for hepatocellular carcinoma. In-house manufacturing will help Senti maintain control over supply and quality, and is being designed to provide end-to-end manufacturing, as well as storage for the final product, the company said.

Tom Hochuli, Vibalogics CEO

Vi­ral man­u­fac­tur­er Viba­log­ics plots out ex­pan­sion at Ger­man site as US growth plans are un­der­way

A German CDMO specializing in viral manufacturing is expanding its operations in Europe by building out an existing plant — and soon, it will be its own landlord, too.

Vibalogics has begun the first stage of a $50 million expansion of its Cuxhaven, Germany facility, the company announced. It will also buy the site outright from the current owner.

The CDMO specializes in the production of oncolytic viruses and viral vector-based vaccines and gene therapy products. The expansion will add another 100,000 square feet at the site for quality batch release and stability studies, drug product fill-finish and process development.

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Michael Chambers (L) and John Ballantyne

Dana­her strikes deal to buy boom­ing next-gen man­u­fac­tur­er Alde­vron for $9.6B

Life sciences conglomerate Danaher Corp. $DHR has struck a deal to buy the fast-growing Aldevron, one of the world’s top manufacturers of hotly sought-after plasmid DNA, mRNA and recombinant proteins for the burgeoning world of vaccine and drugmakers pushing some game-changing technologies.

Buyout talks set the stage for Danaher to settle on a $9.6 billion cash pact to acquire the private Fargo, ND-based company — a key supplier for a disruptive new Covid vaccine as well as a host of gene and cell therapy and CRISPR gene editing players — founded by Michael Chambers and CSO John Ballantyne as a crew of 2 back in 1998.

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Siddhartha Mukherjee, AP Images

Sid Mukher­jee's Vor adds clin­i­cal man­u­fac­tur­ing fa­cil­i­ty at ex­ist­ing Boston-area site, beef­ing up for a com­mer­cial push

When Siddhartha Mukherjee founded Vor Biopharma in 2016, he had the goal of rewriting the book on stem cell transplants. To get there, Vor needed a leg up in clinical manufacturing — and now it has one.

Vor will build an in-house clinical manufacturing facility next to its Cambridge, MA headquarters, which is anticipated to be up and running in 2022, the company said Thursday. The outlay is all out of pocket, but Vor says the buildout won’t impact its cash runway, which is sufficient to early 2023.

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Bay­er flush­es mon­ey in­to the Nordics with $303M down pay­ment on new Finnish plant, ex­pan­sion

At the start of the year, drug giant Bayer telegraphed its intent to ramp up production of contraceptives to help support countries in need. Now, the company is building a new plant in Finland and modernizing an existing plant to help reach that goal.

The project will cost $303 million and expand the company’s footprint in Turku, Finland’s oldest city. The plant is expected to go online by 2025.

Re­call re­port: An­oth­er drug­mak­er is pulling its ver­sion of met­formin off shelves af­ter a car­cino­gen scare

Yet another company has voluntarily recalled lots of generic metformin hydrochloride, marking the ninth recall since the start of the year for the Type 2 diabetes drug.

Viona Pharmaceuticals has issued a recall for two lots of its 750 mg extended-release tablets, the FDA said. The product was recalled after there were levels of nitrosodimethylamine — NDMA for short — above the acceptable daily limit. NDMA has cancer-causing potential, and is sometimes found in meats, dairy products and vegetables.

As it ex­pands its foot­print, Mod­er­na reach­es deal to com­mer­cial­ize Covid-19 vac­cine dos­es in Mid­dle East

While the UAE leads the world with the highest percentage of residents vaccinated, neighboring Saudi Arabia — home to nearly 35 million people — has lagged behind significantly. On Friday, Moderna announced that it has partnered with the Saudi pharmaceutical company Tabuk to commercialize its jab and future variant-specific boosters in the country.

Tabuk will hold marketing authorization for the vaccine in Saudi Arabia, and the agreement gives them the possibility of distributing future Moderna mRNA products.

Ugur Sahin, AP Images

Covid-19 man­u­fac­tur­ing roundup: BioN­Tech an­nounces plans to pro­duce mR­NA vac­cines in Africa; As­traZeneca de­liv­er­ies from Thai­land de­layed

BioNTech, Pfizer’s partner on its Covid-19 vaccine, will look to establish mRNA vaccine production facilities in Africa, the Financial Times reported Wednesday.

The move is a part of a larger push to tackle diseases beyond Covid-19, and as the EU looks to up its manufacturing capacity on the continent. Right now, Africa imports over 99% of the vaccines it uses, the FT reports. The plan was outlined in a call between CEO Ugur Sahin and European Commission President Ursula von der Leyen before the G7 summit.