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Ugur Sahin, BioNTech CEO (Andreas Arnold/picture-alliance/dpa/AP Images)

Flex­ing its new­found wealth, BioN­Tech snaps up a TCR plat­form and man­u­fac­tur­ing site as Gilead ex­its

BioNTech is putting some of its new-found wealth from its star mRNA vaccine for Covid-19 to use. The biotech $BNTX, which now weighs in with a behemoth $56 billion market cap, is buying a cell therapy R&D platform plus a manufacturing site from Gilead’s Kite sub.

The deal — which rather oddly comes without any numbers from the public German biotech company — gives BioNTech Kite’s R&D IP for its personalized neoantigen TCR work as well as the manufacturing center it has in Gaithersburg, MD, which supplies clinical trial product.

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FDA sup­ports lim­it­ed dis­tri­b­u­tion of an­ti­smok­ing drug Chan­tix de­spite car­cino­gen risk

Earlier this month, the FDA alerted the public that Pfizer had voluntarily recalled its stop-smoking drug Chantix after finding elevated levels of cancer-causing nitrosamines. Now, the FDA is permitting certain manufacturers to temporarily distribute the drug that has more than the usual nitrosamine, so long as it remains under the interim acceptable limit.

Pfizer previously halted distribution of Chantix and pulled four lots of the drug after finding unacceptably high levels of the nitrosamine N-nitroso-varenicline in routine testing. In guidance released Friday, the FDA set an interim allowable limit for that compound in Chantix at 185 ng per milliliter to help ensure adequate supply of the drug in the US.

CD­MO AM­RI re­brands and snags a pair of small­er com­pa­nies to aid its shift to be­come a glob­al brand name

The folks at contract manufacturer AMRI were looking to transform their business into a disruptor. They first started with a name change — AMRI is now Curia — and then locked down two acquisitions they hope will take the company into the future.

Curia this week acquired LakePharma, a biotech with headquarters in California’s Bay Area and locations in Massachusetts and Texas as well. The company and its employees will help with large and small molecules from drug discovery through fill-finish manufacturing. A day earlier, Curia announced the acquisition of Integrity Bio, a formulation and fill-finish company from Camarillo, CA.

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Geoff McDonough, CEO (Generation Bio)

Gen­er­a­tion Bio snaps up Boston area plant as it rolls out a man­u­fac­tur­ing process it thinks will be a game chang­er

Generation Bio is looking to move the field of gene therapy into the future, and thinks it has a manufacturing process in place that will allow enough scale for broad disease indications. Now, all it needs is a plant to put those large-scale ambitions into action.

Generation signed a lease on a new 104,000-square-foot facility in Waltham, MA, set to become operational in 2023. The facility will be available for preclinical and clinical development for its lead hemophilia A program.

Catal­ent lands 2 new part­ner­ships, in­clud­ing for glioblas­toma drug; US drops $153M in­to pan­dem­ic pre­pared­ness

It’s been a quiet few weeks for one of the busiest CDMOs out there, but Catalent broke its lull with the announcement of two partnerships this week.

Curtana Pharmaceuticals, an Austin, TX-based preclinical company, announced a partnership with the manufacturer Thursday to make CT-179, its drug therapy for glioblastoma, medulloblastoma and other brain cancers.

CT-179 is a selective small molecule inhibitor of LIG2, a transcription factor essential to early brain development but often not expressed in adult brain cells. The development will take place at Catalent’s San Diego facility.

Steve Harr, Sana CEO

As its next big bet, Sana inks long-term lease for man­u­fac­tur­ing site for next-gen cell ther­a­pies

A unicorn multiple times over, Sana Biotechnology hit Nasdaq running in February with its next-gen cell therapies still months away from the clinic. Now, Sana is looking to the future once again and clearing out some elbow room for its manufacturing team.

Sana has entered a long-term lease to develop a 163,000-square-foot manufacturing facility in California to advance its late-stage clinical development and early commercial launches.

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Jaime Shamonki, Generate CMO

Al­ready sit­ting on a ma­jor stem cell bank, Gen­er­ate looks to grow its re­gen­er­a­tive med­i­cines busi­ness

Generate Life Sciences is the largest private newborn stem cell biorepository, and with the announcement of its own in-house manufacturing facility, the company is looking to grow its regenerative medicine pipeline.

Generate has established a facility in La Jolla, CA, to provide end-to-end manufacturing for newborn stem cell biologics. The site will allow Generate to evolve as it adds a personalized therapeutics developer to its current business model. The new site has been designed to harness mesenchymal stem cells from the tissue of the umbilical cord.

Covid-19 man­u­fac­tur­ing roundup: FDA frees up more Emer­gent vac­cine dos­es; Pfiz­er and Viet­nam dis­cuss tech trans­fer — re­port

The FDA has freed up yet another batch of J&J Covid-19 vaccines that were held up due to contamination at Emergent’s Baltimore Bayview plant.

In a letter addressed to J&J’s North American Regulatory leader Ruta Walawalkar, the agency re-issued emergency use authorization to one more batch on July 13. That will free up another 10 million doses Bloomberg reports.

“I am waiving Current Good Manufacturing Practice requirements for this batch, and only this batch, for the duration of this EUA,” the letter, signed by director of vaccines and research Marion Gruber, says. “This concurrence does not add any other batches manufactured at this facility to the EUA at this time and does not add the facility itself to the EUA at this time, nor does the EUA cover vaccine manufactured by combining this batch with different batches of drug substance that are not authorized explicitly under this EUA.”

Fabian Gerlinghaus (Cellares)

A cou­ple months af­ter land­ing $100 mil­lion in fund­ing, Cel­lares grabs part­ner for its Cell Shut­tle

The team at Cellares hopes that its Cell Shuttle is the future of end-to-end cell therapy manufacturing. On Wednesday, the company announced that one more company has signed up to work alongside it.

Poseida has signed on to provide therapies for the Cell Shuttle, a portable factory Cellares hopes will disrupt the expensive and logistically complicated cell therapy manufacturing process. The company is the third to ink a deal with Cellares, which is based out of South San Francisco, CA. Cellares has already has been collaborating with PACT Pharma and the Fred Hutchinson Cancer Research Center.

Paul Hastings (Nkarta)

Nkar­ta signs its name to an am­bi­tious fu­ture with man­u­fac­tur­ing hub for not one but mul­ti­ple mar­ket­ed drugs

Riding science out of Dario Campana’s famed lab in Singapore, West Coast biotech Nkarta has been a high-profile entry into the race for the industry’s first natural killer cell-based therapy. The biotech, miles away from a potential approval, is doubling down on its own ambition and setting up a manufacturing facility of the future far in advance.

Nkarta has signed a lease on an 88,000-square-foot facility in South San Francisco that will act as the biotech’s new headquarters as well as the home of its commercial manufacturing operations, the company said Wednesday.