North Carolina governor Roy Cooper, left, elbow bumps with Fujifilm Diosynth Biotechnologies CEO Martin Meeson (Ethan Hyman/The News & Observer via AP Images)

Drum­roll, please: Fu­ji­film Diosynth picks North Car­oli­na as new home for $2B cell-cul­ture su­per­plant

Fu­ji­film made waves ear­li­er this year when it an­nounced a new $2 bil­lion plant for its CD­MO arm — Fu­ji­fulm Diosynth Tech­nolo­gies — that few fa­cil­i­ties have matched in terms of dol­lar fig­ure. The on­ly thing left to de­cide is where ex­act­ly the fa­cil­i­ty would go, and now that mys­tery has been solved.

Fu­ji­film Diosynth Biotech­nolo­gies, the CD­MO arm of Japan’s tech and life sci­ences gi­ant, has se­lect­ed Hol­ly Springs, NC, as the site of its $2 bil­lion cell cul­ture su­per­plant, adding 725 jobs in the area by 2028, the com­pa­ny said Thurs­day.

Fu­ji­film had been search­ing for a home for the plant af­ter an­nounc­ing its in­tent to build back in Jan­u­ary. The com­pa­ny eyed lo­ca­tions with­in shout­ing dis­tance of its ex­ist­ing US sites in Col­lege Sta­tion, TX, and Mor­risville, NC.

Ul­ti­mate­ly, North Car­oli­na won the lot­tery due to its “strong pool of tech­ni­cal tal­ent, lo­cal re­sources and part­ners with the right com­pe­ten­cies, clean en­er­gy re­sources, and sus­tain­abil­i­ty for fu­ture growth,” Fu­ji­film said in a re­lease.

Ren­der­ing of the fu­ture Hol­ly Springs site — via Fu­ji­film

Click on the im­age to see the full-sized ver­sion

The plants will come on­line in spring 2025 and house eight 20,000-liter biore­ac­tors with the po­ten­tial to ex­pand and add a fur­ther 24 biore­ac­tors of the same size “based on mar­ket de­mand,” the com­pa­ny says. The site will al­so in­clude com­mer­cial-scale, au­to­mat­ed fill-fin­ish and as­sem­bly, pack­ag­ing and la­belling ser­vices.

The site will ri­val in size the equal­ly mas­sive $2 bil­lion plant Ko­re­an gi­ant Sam­sung is plan­ning in In­cheon. That fa­cil­i­ty, al­so fo­cused on bi­o­log­ics, will cov­er about 2.5 mil­lion square feet, Sam­sung said back in Sep­tem­ber. It will add 256KL to Sam­sung’s over­all man­u­fac­tur­ing ca­pac­i­ty, bring­ing the com­pa­ny’s to­tal to 620KL.

The Hol­ly Springs plant is on­ly one arm of Fu­ji­film’s state­side ex­pan­sion plans as it boosts it con­tract man­u­fac­tur­ing work for Covid-19 vac­cines, in­clud­ing mak­ing the vi­ral vec­tors that de­liv­er J&J’s one-shot vac­cine.

In Jan­u­ary, the firm an­nounced it would drop $40 mil­lion to es­tab­lish a new head­quar­ters in the greater Boston area, which will al­so func­tion as its third vi­ral-vec­tor man­u­fac­tur­ing site.

The Boston fa­cil­i­ty is set to be­gin process de­vel­op­ment analy­ses and ex­per­i­ments for con­di­tion­ing cell cul­ti­va­tion by the fall of 2021. The ca­pac­i­ty for drug sub­stance man­u­fac­tur­ing in ear­ly-stage clin­i­cal tri­als will come lat­er, in fall 2023, the com­pa­ny said in a press re­lease at the time.

Fu­ji­film has al­so re­cent­ly ex­pand­ed its vi­ral-vec­tor plant in Texas — that fa­cil­i­ty opened in 2014 and has since un­der­gone a $120 mil­lion build­out to fur­ther in­crease man­u­fac­tur­ing ca­pac­i­ty. In Oc­to­ber, the com­pa­ny al­so an­nounced plans for a gene ther­a­py site in the UK, which it said would be op­er­a­tional by this spring.

Big Phar­ma's Twit­ter ex­o­dus; Mer­ck wa­gers $1.35B on buy­out; $3.5M gene ther­a­py; and more

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Paul Perreault, CSL Behring CEO

CSL lands FDA ap­proval for he­mo­phil­ia B gene ther­a­py, sets $3.5M list price

The FDA has approved the world’s first gene therapy for hemophilia B, ushering into the market a treatment that’s historic in both what it promises to do and how much it will cost.

CSL will be marketing the drug, Hemgenix, at a list price of $3.5 million — which sets a new record for the most expensive single-use gene therapy in the US.

In a statement provided to Endpoints News, the Australian company noted that the current costs of treating people with moderate to severe hemophilia B can be significant over a lifetime. By some estimates, healthcare systems could spend more than $20 million per person.

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Image: Shutterstock

MIT re­searchers re­veal DNA "Paste" tech be­hind lat­est gene edit­ing start­up

MIT scientists have developed a tool that they say can insert large gene sequences where they want in the genome.

In a paper published Thursday in Nature Biotechnology, MIT fellows Omar Abudayyeh, Jonathan Gootenberg and colleagues detail a technology they call PASTE, which they say can potentially be used to insert long strands of DNA and treat genetic diseases caused by many different mutations, such as cystic fibrosis and Leber congenital amaurosis, a rare eye disorder that causes blindness.

Elon Musk (GDA via AP Images)

Biggest drug com­pa­nies halt­ed Twit­ter ad buys af­ter Lil­ly in­sulin spoof

Almost all of the drug industry’s biggest advertisers cut their spending on Twitter to zero or near-zero over the last two weeks amid worries about impersonation of their brands by pranksters and the future of the social media company.

Among 18 of the biggest pharmaceutical advertisers in the US market, 12 cut their Twitter ad spending to nothing for the week beginning Nov. 14, according to Pathmatics, which tracks data on prescription drug ad spending as well as general corporate advertising. The list of drugmakers cutting spending to zero includes Merck, AstraZeneca, Eli Lilly, Novartis, Pfizer and others.

Rob Davis, Merck CEO

Up­dat­ed: No Seagen here: 'Do more' means a small $1.35B pur­chase of Ima­go for Mer­ck

Merck is making an acquisition, the Big Pharma announced before Monday’s opening bell. No, Seagen is not entering the fold, as had been speculated for quarters.

Folding under Merck’s wings will be Pfizer-backed Imago BioSciences. For nearly a year, Merck CEO Rob Davis has been saying the pharma giant needs to “do more” on the business development front after its 2021 $11.5 billion acquisition of Acceleron.

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Fu­ji­film to build $188M man­u­fac­tur­ing plant in North Car­oli­na’s re­search tri­an­gle

As the Japanese conglomerate Fujifilm continues to invest heavily in its CDMO arm, one of its manufacturing divisions is teeing up a major investment.

Fujifilm Irvine Scientific announced on Tuesday that parent Fujifilm is making a $188 million investment to build a cell culture media manufacturing site in the Research Triangle Park in North Carolina. The new site will mark Fujifilm Irvine’s fifth manufacturing site globally and its second in the US.

J&J's Spra­va­to pulls a PhI­II win against Sero­quel XR in treat­ment-re­sis­tant de­pres­sion

A day before Thanksgiving, J&J’s Janssen has a new cut of Phase III Spravato data to be grateful for.

The pharma giant announced on Wednesday that its nasal spray, also known as esketamine, beat extended-release quetiapine, previously sold by AstraZeneca as Seroquel XR, in treatment-resistant depression (TRD). Of 676 adults, a significantly higher number of patients on Spravato were able to achieve remission and avoid relapse after 32 weeks, according to J&J.

Sus­pend­ed Cal­i­for­nia cell ther­a­py man­u­fac­tur­ing site hit with FDA warn­ing let­ter over ma­jor qual­i­ty con­cerns

A cell therapy outfit in California that manufactures a human umbilical cord derived cellular product and exosome products is facing a warning from the FDA over several major observations related to quality.

The FDA notes the site’s “deficient donor screening practices, inadequate aseptic practices, unvalidated manufacturing,” and the “risk that your products may be contaminated with microorganisms or have other serious product quality defects.”

Dermavant Sciences' first consumer TV ad for its Vtama psoriasis med shows people ready for a new topical treatment.

Roivant’s Der­ma­vant de­buts first-ever TV com­mer­cial for pso­ri­a­sis cream Vta­ma

Dermavant Sciences has been marketing its first product, psoriasis med Vtama, to dermatologists for months, but on Tuesday it rolled out its first consumer campaign. The debut DTC effort including a streaming TV commercial encourages patients to a “Topical Uprising” in a nod to Vtama being a topical cream.

In the new commercial, a swell of people discards scarves and jacket coverings, gathering in the street to converge on a pharmacy to demand a steroid-free prescription. A moment of levity follows when a pharmacist says, “You know you can just talk to your doctor, right?” The gathered crowds collectively says, “Oh.”

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